78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100

  
464 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04867317
(ClinicalTrials.gov)
March 1, 20228/4/2021AGH Replacement Therapy With mTBICSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone Deficiency;Mild Traumatic Brain InjuryDrug: Somatropin;Other: PlaceboVA Office of Research and DevelopmentNULLNot yet recruiting21 Years55 YearsAll172Phase 3United States
2NCT05250063
(ClinicalTrials.gov)
February 18, 202210/2/2022Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial LUM-201-01 Trial (OraGrowtH213 Trial)A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 TrialGrowth Hormone DeficiencyDrug: LUM-201Lumos PharmaNULLEnrolling by invitation3 Years13 YearsAll20Phase 2United States
3NCT05230550
(ClinicalTrials.gov)
February 3, 202228/1/2022Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in JapanAdult Growth Hormone DeficiencyDrug: SomapacitanNovo Nordisk A/SNULLEnrolling by invitationN/AN/AAll200Japan
4EUCTR2020-000929-42-BG
(EUCTR)
07/01/202220/01/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
Product Name: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden
5NCT05171855
(ClinicalTrials.gov)
December 16, 202124/9/2021A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone DeficiencyA Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone DeficiencyAdult Growth Hormone Deficiency;Endocrine System Diseases;Hormone DeficiencyDrug: LonapegsomatropinAscendis Pharma Endocrinology Division A/SNULLRecruiting23 Years81 YearsAll240Phase 3United States
6JPRN-jRCT2031210366
15/11/202105/10/2021An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiencyAn extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency Growth hormone deficiency in children[Investigational product]
JR-142
0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection
[Comparatar product]
INN: Somatropin
0.175 mg/kg/week, daily subcutaneous injection
Ioroi MinoruNULLNot RecruitingNot applicableNot applicableBoth24Phase 2Japan
7EUCTR2020-000929-42-IT
(EUCTR)
18/10/202108/06/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: Norditropin FlexPro 5mg/1.5 ml
Product Code: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden
8NCT04786873
(ClinicalTrials.gov)
September 20213/3/2021A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it isMulticenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: Macimorelin;Diagnostic Test: Arginine;Diagnostic Test: ClonidineAEterna ZentarisNovo Nordisk A/SRecruiting2 Years17 YearsAll100Phase 3United States
9NCT04938466
(ClinicalTrials.gov)
August 5, 202116/6/2021Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone TherapyAssessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone TherapyGrowth Hormone Deficiency;Growth Hormone TreatmentDrug: Long-Acting Growth Hormone (LAGH)University of MinnesotaNULLRecruiting2 Years13 YearsAll80United States
10EUCTR2020-000929-42-DK
(EUCTR)
05/08/202112/01/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
11EUCTR2018-001989-42-PL
(EUCTR)
04/08/202129/06/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy
12EUCTR2018-001989-42-IT
(EUCTR)
03/08/202130/08/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects
MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
Product Code: [-]
INN or Proposed INN: CLONIDINA CLORIDRATO
Other descriptive name: Clonidine hydrochloride
Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: [AEZS-130]
INN or Proposed INN: macimorelina
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene
Product Name: Arginine Hydrochloride
Product Code: [NDC0009-0436-01]
INN or Proposed INN: ARGININA CLORIDRATO
Other descriptive name: ARGININE HYDROCHLORIDE
AETERNA ZENTARIS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy
13ChiCTR2100048579
2021-08-012021-07-11Efficacy and Safety of JINTROLONG for Transitional Growth Hormone DeficiencyEfficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency (TGHD) Transitional Growth Hormone DeficiencyExperimental group:polyethylene glycol recombinant human growth hormone injection;The Children's Hospital of Zhejiang University School of MedicineNULLPending26BothExperimental group:23;Phase 4China
14NCT04970654
(ClinicalTrials.gov)
July 22, 202112/7/2021A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin®Novo Nordisk A/SNULLRecruiting2 Years11 YearsAll108Phase 3China
15JPRN-jRCT2031200340
14/06/202102/02/2021A trial to compare lonapegsomatropin (TransCon hGH) administered once a week and standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency (GHD)A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the efficacy, safety, and tolerability of lonapegsomatropin (TransCon hGH) administered once a week versus standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency(GHD) - riGHt Pediatric growth hormon deficiency

Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector.
Genotropin will be administered as daily SC injections in a standard dose of 0.24 mg hGH/kg/week.
The total weekly dose will be equally split into 7 daily doses of 0.034 mg hGH/kg/day. A commercially approved injection device will be used for administration of the drug.

Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector.

Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector.
Beckert MichaelNULLRecruiting>= 3age old<= 16age oldBoth50Phase 3Japan
16EUCTR2020-000929-42-DE
(EUCTR)
09/06/202114/10/2020Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Japan;New Zealand;Germany;Bulgaria;Georgia;Romania;Poland;Canada;Armenia;United Kingdom;Turkey;Netherlands;Denmark;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia
17JPRN-jRCT2051200129
02/06/202102/02/2021A trial to compare once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyA multicenter, randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)-Drug: Lonapegsomatropin
Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
-Other: Placebo
The placebo for lonapegsonatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin.
-Drug: Somatropin
Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
Beckert MichaelNULLRecruiting>= 23age old<= 80age oldBoth240Phase 3Australia;Belarus;Bulgaria;Canada;Denmark;France;Georgia;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Poland;Romania;Russia;Serbia;Slovakia;Spain;Turkey;UK;Ukraine;USA;Armenia;Japan
18NCT04806854
(ClinicalTrials.gov)
June 202117/3/2021PK and PD Study of LUM-201 in Children With Growth Hormone DeficiencyA Single-Center, 6-Month, Randomized, Open-Label, Parallel Arm Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Pediatric Growth Hormone Deficiency (PGHD)Growth Hormone DeficiencyDrug: LUM-201Lumos PharmaNULLRecruiting4 Years9 YearsAll24Phase 2Chile
19EUCTR2020-000929-42-ES
(EUCTR)
21/04/202101/02/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
Product Name: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden
20EUCTR2020-000929-42-SK
(EUCTR)
12/04/202124/11/2020Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
21EUCTR2020-000929-42-GR
(EUCTR)
23/03/202104/03/2021foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand
22EUCTR2020-000874-92-PL
(EUCTR)
22/03/202126/10/2020A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD)A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD) - LUM-201-01 Growth hormone deficiency
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: LUM-201
INN or Proposed INN: Ibutamoren mesilate
Other descriptive name: IBUTAMOREN MESILATE
Product Name: LUM-201
INN or Proposed INN: Ibutamoren mesilate
Other descriptive name: IBUTAMOREN MESILATE
Product Name: LUM-201
INN or Proposed INN: Ibutamoren mesilate
Other descriptive name: IBUTAMOREN MESILATE
Trade Name: Norditropin
INN or Proposed INN: recombinant human growth hormone
Other descriptive name: recombinant human growth hormone
Trade Name: Norditropin
INN or Proposed INN: recombinant human growth hormone
Other descriptive name: recombinant human growth hormone
Lumos Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Poland;Ukraine;Australia;Russian Federation;Israel;New Zealand
23JPRN-jRCT2031200372
01/03/202119/02/2021Phase 2 study of JR-142 in pediatric patients with growth hormone deficiencyPhase 2 study of JR-142 in pediatric patients with growth hormone deficiency Growth hormone deficiency in children[Investigational product]
JR-142
0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection
[Comparatar product]
INN: Somatropin
0.175 mg/kg/week, daily subcutaneous injection
Ioroi MinoruNULLRecruiting>= 3age old< 10age oldBoth24Phase 2Japan
24NCT04633057
(ClinicalTrials.gov)
January 25, 202112/11/2020A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone DeficiencyA Phase III, Randomized, Open-label, Positive-controlled, Multi-center Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: TJ101;Drug: NordiFlexI-Mab Biopharma Co. Ltd.NULLRecruiting3 Years12 YearsAll165Phase 3China
25NCT04614337
(ClinicalTrials.gov)
December 31, 202026/10/2020Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: LUM-201;Drug: rhGH Norditropin® pen (34 µg/kg)Lumos PharmaNULLRecruiting3 Years12 YearsAll80Phase 2United States;Australia;Israel;New Zealand;Poland;Russian Federation;Ukraine
26NCT04615273
(ClinicalTrials.gov)
December 3, 202029/10/2020A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyforesiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyGrowth Hormone Deficiency;Endocrine System Diseases;Hormone DeficiencyDrug: Lonapegsomatropin;Other: Placebo;Drug: SomatropinAscendis Pharma Endocrinology Division A/SNULLRecruiting23 Years80 YearsAll240Phase 3United States;Armenia;Australia;Canada;Georgia;Greece;Japan;Poland;Slovakia;Turkey;Ukraine
27ChiCTR2000039505
2020-12-012020-10-30An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiencyAn exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency Adult growth hormone deficiencyexperimental group:Recombinant Human Growth Hormone;Huashan Hospital Affiliated to Fudan UniversityNULLRecruiting1850Maleexperimental group:20;China
28NCT04465565
(ClinicalTrials.gov)
December 20203/7/2020Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation TestFluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled StudyGrowth Hormone DeficiencyProcedure: 9% Sodium Chloride (NaCl) IVRabin Medical CenterNULLWithdrawn7 Years16 YearsAll0N/AIsrael
29EUCTR2018-000231-27-ES
(EUCTR)
21/04/202028/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
30EUCTR2018-000231-27-HU
(EUCTR)
23/03/202005/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of
31EUCTR2018-000231-27-PL
(EUCTR)
23/03/202004/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Germany;Norway;Japan;United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland
32EUCTR2018-000231-27-LV
(EUCTR)
05/03/202015/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Germany;Latvia;Norway;Algeria;Japan;Korea, Republic of
33EUCTR2018-000231-27-EE
(EUCTR)
17/02/202014/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
34NCT04326374
(ClinicalTrials.gov)
December 30, 201926/3/2020Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone DeficiencyThe Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in ChinaGrowth Hormone Deficiency;Endocrine System Diseases;Hormones;Pituitary Diseases;Pituitary Disease, AnteriorDrug: TransCon hGH;Drug: daily hGHVisen Pharmaceuticals (Shanghai) Co., Ltd.Ascendis Pharma A/SRecruiting3 Years17 YearsAll150Phase 3China
35NCT04121780
(ClinicalTrials.gov)
October 8, 201925/9/2019Growth Hormone Replacement Therapy for Retried Professional Football PlayersInterventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone DeficiencyTBI (Traumatic Brain Injury);Concussion, Brain;Sport Injury;Anterior Pituitary Hyposecretion Syndrome;Hypopituitarism;Growth Hormone DeficiencyBiological: Growth Hormone;Other: PlaceboCenter for Neurological StudiesNovo Nordisk A/SRecruiting18 Years76 YearsMale42Phase 2United States
36NCT04020913
(ClinicalTrials.gov)
July 22, 201924/5/2019Skeletal Muscle Effects of GH in BoysRecombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH DeficiencyGrowth Hormone Deficiency;Idiopathic Short StatureDrug: Somatropin injectionNemours Children's ClinicNovo Nordisk A/SRecruiting6 Years11 YearsMale45United States
37EUCTR2018-000231-27-SI
(EUCTR)
17/07/201914/06/2019A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Japan
38EUCTR2018-000918-38-BG
(EUCTR)
16/07/201923/05/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
39EUCTR2018-000918-38-SK
(EUCTR)
11/07/201911/02/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
40EUCTR2018-000918-38-CZ
(EUCTR)
27/06/201920/03/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
41NCT03972345
(ClinicalTrials.gov)
June 21, 201931/5/2019Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)Growth Hormone Deficiency in Children;Born Small for Gestational AgeDrug: Norditropin® FlexPro®Novo Nordisk A/SNULLEnrolling by invitationN/A15 YearsAll750Germany
42EUCTR2018-000231-27-GB
(EUCTR)
30/05/201903/09/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Norway;Germany;Algeria;Japan;Korea, Republic of
43EUCTR2018-000231-27-AT
(EUCTR)
22/05/201902/04/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
44NCT03811535
(ClinicalTrials.gov)
May 20, 201918/1/2019A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a DayA Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenDrug: Somapacitan;Drug: Norditropin®Novo Nordisk A/SNULLActive, not recruiting2 Years11 YearsAll200Phase 3United States;Algeria;Austria;Canada;Denmark;Estonia;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Norway;Poland;Russian Federation;Serbia;Slovenia;Spain;Switzerland;Thailand;Ukraine;United Kingdom
45NCT03500913
(ClinicalTrials.gov)
May 19, 201910/4/2018Adipose Tissue and Serum Inflammation in GH DeficiencyAdipose Tissue and Serum Inflammation in Growth Hormone (GH) DeficiencyGrowth Hormone DeficiencyDrug: Growth HormoneColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years65 YearsAll60United States
46EUCTR2018-000918-38-GB
(EUCTR)
16/05/201927/11/2018STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
47EUCTR2018-000231-27-DK
(EUCTR)
15/05/201928/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Algeria;Japan
48NCT03878992
(ClinicalTrials.gov)
April 30, 20197/3/2019Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleEffects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleGrowth Hormone Deficiency;Growth Hormone TreatmentDrug: Genotropin miniquick 0.5 mg, injectionUniversity of AarhusAarhus University HospitalRecruiting18 Years100 YearsAll12N/ADenmark
49EUCTR2018-000231-27-DE
(EUCTR)
23/04/201911/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
50EUCTR2018-000231-27-IT
(EUCTR)
19/04/201930/07/2021A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290S
Product Code: [NN8640]
INN or Proposed INN: Somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Product Name: Norditropin FlexPro 10 mg/1.5 ml
Product Code: [N/A]
INN or Proposed INN: somatropin
Other descriptive name: somatropin
NOVO NORDISK. S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan
51EUCTR2018-001988-23-PL
(EUCTR)
19/04/201923/01/2019A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD)Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) Diagnosis of Growth Hormone Deficiency
MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Macrilen
Product Name: macimorelin
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Belarus;Hungary;Poland;Ukraine;Russian Federation
52NCT03775993
(ClinicalTrials.gov)
March 1, 201912/12/2018Treatment of GHD Associated With CHFTreatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled StudyHeart Failure;Growth Hormone DeficiencyDrug: Human growth hormone;Other: PlaceboFederico II UniversityNULLNot yet recruiting18 Years85 YearsAll64Phase 3NULL
53NCT03831880
(ClinicalTrials.gov)
February 7, 201921/12/2018Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHDA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYGrowth Hormone DeficiencyDrug: Genotropin;Drug: somatrogonPfizerNULLCompleted3 Years17 YearsAll87Phase 3United States;Bulgaria;Czechia;Slovakia;United Kingdom
54NCT04513171
(ClinicalTrials.gov)
December 26, 20187/8/2020Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency ChildrenA Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.Growth Hormone DeficiencyDrug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: NorditropinXiamen Amoytop Biotech Co., Ltd.Tongji HospitalRecruiting3 Years11 YearsAll400Phase 2/Phase 3China
55EUCTR2018-001988-23-HU
(EUCTR)
07/11/201805/09/2018A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD)Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) Diagnosis of Growth Hormone Deficiency
MedDRA version: 20.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Macrilen
Product Name: macimorelin
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Hungary;Poland;Ukraine;Russian Federation
56EUCTR2017-003410-20-IT
(EUCTR)
30/10/201811/10/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany
57EUCTR2017-003410-20-PL
(EUCTR)
23/10/201808/11/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany
58ChiCTR1800017144
2018-07-252018-07-13A diverse response study of Pegylated Somatropin to treat growth hormone deficiency childrenA diverse response study of Pegylated Somatropin to treat growth hormone deficiency children Growth hormone deficiencyTwo groups:low dose versus high dose of Pegylated Somatropin;The Children's Hospital, Zhejiang University School of MedicineNULLRecruiting314BothTwo groups:900;China‘
59EUCTR2017-003410-20-GR
(EUCTR)
04/06/201819/04/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand
60NCT03274973
(ClinicalTrials.gov)
May 14, 201829/8/2017Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner SyndromeA Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner SyndromeGrowth DisordersDrug: ZomactonFerring PharmaceuticalsNULLTerminatedN/A18 YearsAll4Germany
61EUCTR2017-003410-20-BG
(EUCTR)
20/04/201809/01/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand
62EUCTR2016-001145-11-DE
(EUCTR)
12/02/201814/12/2016A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenA multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011) - 12.1mg
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: TransCon hGH (ACP-011) - 24.2mg
Ascendis Pharma Endocrinology Division A/SNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine
63JPRN-JapicCTI-183963
25/12/201717/05/2018Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY Treatment of children with growth failure due to growth hormone deficiency (GHD)Intervention name : Somatrogon (Genetical Recombination)
INN of the intervention : somatrogon
Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Control intervention name : Genotropin
INN of the control intervention : somatropin
Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day).
OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd)NULLcomplete311BOTH44Phase 3Japan
64EUCTR2016-003874-42-GR
(EUCTR)
20/12/201721/11/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand
65NCT03344458
(ClinicalTrials.gov)
December 19, 201714/11/2017A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical TrialenliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical TrialGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma A/SNULLActive, not recruiting1 Year18 YearsAll300Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine
66NCT03874013
(ClinicalTrials.gov)
December 7, 20171/10/2018Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: MOD-4023;Drug: GenotropinOPKO Health, Inc.NULLCompleted3 Years11 YearsAll44Phase 3Japan
67NCT03305016
(ClinicalTrials.gov)
November 13, 20174/10/2017A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone DeficiencyfliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHDGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma Endocrinology Division A/SNULLCompleted6 Months17 YearsAll146Phase 3United States;Australia;Canada;New Zealand
68NCT03053687
(ClinicalTrials.gov)
November 1, 20177/2/2017Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of TherapyEffect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled TrialIGHD - Isolated Growth Hormone Deficiency;Growth RetardationDietary Supplement: Nutritional supplementation standardized formula;Dietary Supplement: PlaceboRabin Medical CenterNULLRecruiting3 Years14 YearsAll64N/AIsrael
69EUCTR2016-003874-42-GB
(EUCTR)
04/09/201703/01/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noTaiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus
70NCT03212131
(ClinicalTrials.gov)
August 16, 201730/6/2017Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNULLCompleted18 Years75 YearsAll34Phase 1Slovakia
71EUCTR2016-003874-42-DE
(EUCTR)
04/08/201701/02/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand
72NCT03225755
(ClinicalTrials.gov)
August 1, 201719/7/2017Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH TherapyAdipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH TherapyGrowth Hormone DeficiencyDrug: Growth hormoneColumbia UniversityNovo Nordisk A/SRecruiting18 Years65 YearsAll12United States
73NCT03186495
(ClinicalTrials.gov)
June 20, 201712/6/2017Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal FunctionInvestigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNULLCompleted18 Years75 YearsAll44Phase 1Germany
74EUCTR2016-003874-42-IT
(EUCTR)
16/06/201706/09/2021An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
PRM|21097NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy
75EUCTR2016-003874-42-ES
(EUCTR)
18/05/201714/03/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand
76EUCTR2016-003874-42-BG
(EUCTR)
26/04/201713/02/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand
77EUCTR2016-001145-11-IT
(EUCTR)
07/04/201710/01/2017A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg
INN or Proposed INN: TransCon hGH (ACP-011)
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: Sterile Water for Injection
Ascendis Pharma Endocrinology Division A/SNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden
78NCT03104010
(ClinicalTrials.gov)
April 201728/3/2017A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHDA Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: Somatropin InjectionGeneScience Pharmaceuticals Co., Ltd.Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China HospitalRecruiting18 Years60 YearsAll180Phase 2China
79EUCTR2016-001145-11-PL
(EUCTR)
31/03/201717/01/2017A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011) - 12.1mg
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: TransCon hGH (ACP-011) - 24.2mg
Ascendis Pharma Endocrinology Division A/SNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden
80NCT03145831
(ClinicalTrials.gov)
March 31, 20175/4/2017A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone DeficiencyAn Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomavaratanVersartis Inc.NULLTerminated3 YearsN/AAll21Phase 3United States;Japan
81EUCTR2016-001145-11-GR
(EUCTR)
28/03/201702/02/2017A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenA multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011) - 12,1mg
INN or Proposed INN: TransCon hGH (ACP-011)
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Ascendis Pharma Endocrinology Division A/SNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden
82NCT03075644
(ClinicalTrials.gov)
March 3, 201728/2/2017A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone DeficiencyA Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: NorditropinNovo Nordisk A/SNULLCompleted18 Years79 YearsAll62Phase 3Japan
83NCT03290235
(ClinicalTrials.gov)
March 1, 201719/9/2017Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenThe Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenGrowth RetardationDrug: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting42 Months15 YearsAll1500Phase 4China
84JPRN-UMIN000027260
2017/02/0607/05/2017Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons.Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutesOsaka City University Graduate School of MedicineNULL2years-old15years-oldMale and Female15Not selectedJapan
85EUCTR2016-002780-34-PL
(EUCTR)
30/01/201708/11/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan Growth hormone deficiency
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somavaratan
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Canada;Belgium;Poland;Sweden
86EUCTR2016-002780-34-BE
(EUCTR)
16/12/201619/09/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somavaratan
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Canada;Poland;Belgium;Sweden
87NCT02781727
(ClinicalTrials.gov)
December 13, 201619/5/2016A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone Deficiency, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary DiseasesDrug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of GenotropinAscendis Pharma Endocrinology Division A/SNULLCompleted3 Years12 YearsAll161Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine
88NCT02968004
(ClinicalTrials.gov)
December 201613/11/2016Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenA Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOPKO Health, Inc.NULLActive, not recruiting3 Years11 YearsAll224Phase 3United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey
89EUCTR2016-002780-34-SE
(EUCTR)
10/11/201613/09/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan Growth hormone deficiency
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somavaratan
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Canada;Poland;Belgium;Sweden
90EUCTR2015-001939-21-LV
(EUCTR)
15/08/201631/05/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
91NCT03015909
(ClinicalTrials.gov)
August 11, 201610/11/2016Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable DeviceShort Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner SyndromeDrug: SomatropinLG Life SciencesNULLCompleted4 Years15 YearsAll116Phase 4Korea, Republic of
92NCT03203356
(ClinicalTrials.gov)
May 30, 201626/5/2017Adrenal Function in GHD ChildrenEvaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH DeficiencyGrowth Hormone Treatment;Adrenal; Functional DisturbanceDrug: growth hormoneUniversity of PalermoNULLCompleted5 Years12 YearsAll30N/AItaly
93EUCTR2015-002337-22-IT
(EUCTR)
24/05/201608/06/2021Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: Macimorelin acetate
Trade Name: Humalog Mix50 100 U/ml sospensione iniettabile
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: Insulin
AETERNA ZENTARIS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy
94EUCTR2015-001939-21-LT
(EUCTR)
04/05/201629/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
95EUCTR2015-001939-21-PL
(EUCTR)
19/04/201618/01/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of
96EUCTR2015-002337-22-PL
(EUCTR)
12/04/201601/02/2016Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom
97EUCTR2015-001939-21-EE
(EUCTR)
30/03/201616/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
98NCT02616562
(ClinicalTrials.gov)
March 23, 201625/11/2015Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone DeficiencyA Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin® FlexPro® penNovo Nordisk A/SNULLRecruitingN/A17 YearsAll74Phase 2United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine
99EUCTR2015-000531-32-DE
(EUCTR)
14/03/201620/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
100EUCTR2014-004525-41-PL
(EUCTR)
09/03/201623/02/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH.Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY Growth hormone deficiency
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Belgium;Poland;Netherlands;Sweden
101NCT03223025
(ClinicalTrials.gov)
March 9, 201618/7/2017Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone DeficiencyEfficacy and Safety of CinnaGen Recombinant Human Growth Hormone (CinnaTropin®) in Comparison With Novo Nordisk Growth Hormone (Nordilet®) Product in Pre-Pubertal Children With Idiopathic Growth Hormone Deficiency (IGHD)Idiopathic Growth Hormone DeficiencyDrug: CinnaTropin®;Drug: Nordilet®CinnagenNULLCompleted4 Years16 YearsAll30Phase 3NULL
102EUCTR2015-000531-32-BE
(EUCTR)
17/02/201630/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden
103NCT02719990
(ClinicalTrials.gov)
February 9, 201616/3/2016Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHDAn Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)Adult Growth Hormone Deficiency (AGHD)Drug: somavaratanVersartis Inc.Premier Research Group plcTerminated18 Years75 YearsAll34Phase 2Australia;United States
104EUCTR2015-002337-22-DE
(EUCTR)
19/01/201609/11/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
105NCT03309891
(ClinicalTrials.gov)
January 18, 20165/9/2017Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone DeficiencyA Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.NULLCompleted3 Years11 YearsAll56Phase 2Ukraine
106EUCTR2015-000531-32-SE
(EUCTR)
14/01/201604/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
107EUCTR2014-002736-13-PL
(EUCTR)
08/01/201629/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
108EUCTR2014-003796-32-PL
(EUCTR)
08/01/201629/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Lithuania;Austria;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany
109EUCTR2015-000531-32-SI
(EUCTR)
15/12/201511/11/2015A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
110EUCTR2015-002337-22-AT
(EUCTR)
10/12/201530/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
111EUCTR2015-000531-32-AT
(EUCTR)
10/12/201503/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
112EUCTR2014-002736-13-HR
(EUCTR)
09/12/201501/02/2016A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
113EUCTR2015-002337-22-GB
(EUCTR)
08/12/201528/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
114EUCTR2014-003796-32-HR
(EUCTR)
04/12/201501/02/2016A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
115NCT02558829
(ClinicalTrials.gov)
December 3, 201521/9/2015Validation of Macimorelin as a Test for Adult Growth Hormone DeficiencyConfirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)Growth Hormone Deficiency With Pituitary AnomaliesDrug: Macimorelin;Drug: InsulinAEterna ZentarisNULLCompleted18 Years65 YearsAll157Phase 3United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom
116EUCTR2014-003796-32-RO
(EUCTR)
18/11/201508/10/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
117EUCTR2015-001939-21-GR
(EUCTR)
12/11/201513/10/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia
118EUCTR2015-002072-24-DE
(EUCTR)
22/10/201512/08/2015A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose.An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD)Versartis International Trial in Adults with Long Acting Growth Hormone. The VITAL study - Versartis International Trial in Adults with Long Acting Growth Hormone (VITAL) Growth Hormone Deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somavaratan
Product Code: VRS-317
INN or Proposed INN: Somavaratan
Other descriptive name: VRS-317
Versartis Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Australia;Germany;United Kingdom
119EUCTR2015-001939-21-SK
(EUCTR)
22/10/201527/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
120EUCTR2014-003796-32-SI
(EUCTR)
15/10/201512/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
121EUCTR2014-002736-13-SI
(EUCTR)
15/10/201512/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
122EUCTR2015-001939-21-CZ
(EUCTR)
14/10/201510/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
123EUCTR2013-002892-16-LV
(EUCTR)
12/10/201531/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden
124EUCTR2005-000384-26-FR
(EUCTR)
12/10/201504/10/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
138 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
125EUCTR2014-003796-32-BG
(EUCTR)
07/10/201502/10/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
126EUCTR2014-002736-13-CZ
(EUCTR)
01/10/201510/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
127EUCTR2014-003796-32-CZ
(EUCTR)
01/10/201514/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
128EUCTR2013-002892-16-LT
(EUCTR)
30/09/201527/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
129EUCTR2014-004525-41-NL
(EUCTR)
03/09/201523/03/2015A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH.Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
130EUCTR2014-003796-32-IT
(EUCTR)
25/08/201527/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
131EUCTR2014-002736-13-IT
(EUCTR)
25/08/201527/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
132NCT02339090
(ClinicalTrials.gov)
August 24, 20157/1/2015Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency.Growth DisordersDrug: somavaratan;Drug: Daily rhGHVersartis Inc.NULLCompleted3 Years11 YearsAll136Phase 3Belgium;Canada;Netherlands;Poland;Sweden;United States
133EUCTR2014-003796-32-DE
(EUCTR)
21/08/201516/03/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
134EUCTR2014-003796-32-LT
(EUCTR)
20/08/201514/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
135EUCTR2014-002736-13-LT
(EUCTR)
20/08/201514/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
136EUCTR2014-002736-13-DE
(EUCTR)
19/08/201513/03/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
137NCT02413138
(ClinicalTrials.gov)
August 8, 201523/3/2015Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)Pediatric Growth Hormone Deficiency;Growth DisordersDrug: Somavaratan (VRS-317)Versartis Inc.NULLTerminated3 Years10 YearsAll41Phase 2/Phase 3Japan
138EUCTR2014-003796-32-ES
(EUCTR)
31/07/201508/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
139EUCTR2014-002736-13-ES
(EUCTR)
24/07/201508/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
140EUCTR2015-001939-21-HU
(EUCTR)
16/07/201522/05/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of
141NCT02526420
(ClinicalTrials.gov)
July 201513/8/2015Versartis International Trial in Adults With Long-Acting Growth HormoneAn Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)Adult Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.Premier Research Group plcCompleted23 Years70 YearsBoth36Phase 2United States;Australia;Germany;United Kingdom
142EUCTR2014-002698-13-PL
(EUCTR)
30/06/201522/05/2015A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: N/A
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
143EUCTR2014-002736-13-HU
(EUCTR)
26/06/201510/04/2015A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
144EUCTR2014-002736-13-GR
(EUCTR)
26/06/201510/06/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden;Lithuania;Austria;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey
145EUCTR2014-003796-32-HU
(EUCTR)
26/06/201510/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
146EUCTR2014-003796-32-GR
(EUCTR)
22/06/201515/06/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
147EUCTR2014-002736-13-AT
(EUCTR)
22/06/201504/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
148EUCTR2014-003796-32-AT
(EUCTR)
22/06/201529/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
149EUCTR2014-002698-13-DE
(EUCTR)
11/06/201523/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
150EUCTR2013-004468-69-PL
(EUCTR)
28/05/201505/02/2015A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
151EUCTR2014-002736-13-SE
(EUCTR)
25/05/201521/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
152EUCTR2014-003796-32-SK
(EUCTR)
20/05/201515/01/2016A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment Growth hormone deficiency
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
153EUCTR2014-002736-13-SK
(EUCTR)
20/05/201515/01/2016A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency Growth hormone deficiency
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
154NCT02410343
(ClinicalTrials.gov)
April 30, 201530/3/2015Study of TV-1106 in Growth Hormone-Deficient AdultsA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH TreatmentGrowth Hormone DeficiencyDrug: TV-1106;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 YearsN/AAll14Phase 3Hungary;Italy;Russian Federation;United States;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Serbia;Slovakia;Slovenia;Spain;Turkey;Ukraine;Austria;Czechia;Greece
155NCT02410356
(ClinicalTrials.gov)
April 30, 201530/3/2015A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyA Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: dGHTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 YearsN/AAll34Phase 3United States;Austria;Czechia;Greece;Hungary;Italy;Slovakia;Spain;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey;Ukraine
156EUCTR2014-004525-41-BE
(EUCTR)
22/04/201516/02/2015A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Poland;Belgium;Netherlands;Sweden
157EUCTR2014-004525-41-SE
(EUCTR)
10/04/201512/02/2015A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somavaratan (VRS-317)
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinat human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Poland;Belgium;Netherlands;Sweden
158NCT02311894
(ClinicalTrials.gov)
March 31, 20154/12/2014A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone DeficiencyA Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)Growth Hormone DeficiencyDrug: SomatropinGenentech, Inc.NULLCompleted3 Years14 YearsAll82Phase 4United States
159EUCTR2014-002698-13-GR
(EUCTR)
26/02/201517/03/2015A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
160EUCTR2013-004468-69-BG
(EUCTR)
18/02/201507/10/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
161EUCTR2014-002698-13-HU
(EUCTR)
17/02/201515/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: N/A
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: GX-H9
INN or Proposed INN: N/A
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: GX-H9
INN or Proposed INN: N/A
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
162NCT02382939
(ClinicalTrials.gov)
February 12, 201510/2/2015A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone DeficiencyA Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone DeficiencyAdult Growth Hormone Deficiency;Growth Hormone DisorderDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNULLCompleted18 Years79 YearsAll92Phase 3Denmark;France;Germany;Japan;Sweden;United Kingdom
163EUCTR2014-002698-13-SE
(EUCTR)
03/02/201518/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
164EUCTR2014-000290-39-GB
(EUCTR)
30/01/201522/01/2015A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiencyA multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 Growth hormone deficiency in adults
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
90Phase 3European Union;Denmark;Japan;United Kingdom;Sweden
165EUCTR2013-004468-69-ES
(EUCTR)
22/01/201503/11/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
166EUCTR2014-000290-39-DK
(EUCTR)
22/01/201522/01/2015A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiencyA multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 Growth hormone deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
90Sweden;Japan;United Kingdom;Denmark;European Union
167EUCTR2014-002698-13-SK
(EUCTR)
14/01/201509/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: N/A
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
168NCT02418767
(ClinicalTrials.gov)
January 20158/1/2015Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese VolunteersA Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese VolunteersGrowth Hormone DeficiencyDrug: MOD-4023;Drug: PlaceboOPKO Health, Inc.WCCT GlobalCompleted18 Years45 YearsMale42Phase 1United States
169NCT02946606
(ClinicalTrials.gov)
January 201528/8/2015A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.NULLCompleted20 Years65 YearsAll45Phase 2Korea, Republic of
170NCT02976675
(ClinicalTrials.gov)
January 201524/11/2016Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong UniversityRecruiting3 Years18 YearsAll600Phase 4China
171NCT03249480
(ClinicalTrials.gov)
January 201524/7/2017Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's HospitalRecruiting3 Years18 YearsAll900Phase 4China
172EUCTR2013-002892-16-DE
(EUCTR)
22/12/201429/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
173NCT02380235
(ClinicalTrials.gov)
December 20142/3/2015Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)Growth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 Years18 YearsAll600Phase 4China
174EUCTR2013-002892-16-GB
(EUCTR)
20/11/201424/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
175EUCTR2014-000290-39-SE
(EUCTR)
07/11/201407/10/2014A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiencyA multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 Growth hormone deficiency in adults
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
90European Union;Denmark;United Kingdom;Japan;Sweden
176NCT02314676
(ClinicalTrials.gov)
November 201427/11/2014Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenDwarfism, PituitaryBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 YearsN/ABoth900Phase 4China
177NCT02908958
(ClinicalTrials.gov)
November 201419/9/2016Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone DeficiencyClinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial IIGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second HospitalRecruiting3 Years18 YearsAll900Phase 4China
178NCT02229851
(ClinicalTrials.gov)
October 31, 201426/8/2014Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension PeriodGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted23 Years79 YearsAll301Phase 3United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom
179EUCTR2013-002892-16-SE
(EUCTR)
07/10/201403/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
180NCT02243852
(ClinicalTrials.gov)
September 201416/9/2014Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)Evaluation of the Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) Concentration in Patients With Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: Growth Hormone Replacement TherapyUniversity of LiverpoolPfizerRecruiting18 Years80 YearsBoth48N/AUnited Kingdom
181EUCTR2013-004468-69-CZ
(EUCTR)
08/08/201411/04/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
182EUCTR2013-004468-69-GR
(EUCTR)
29/07/201416/06/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
183NCT02018172
(ClinicalTrials.gov)
July 201417/12/2013Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X DeviceGrowth Hormone Deficiency;Turner's SyndromeDrug: somatropinFerring PharmaceuticalsNULLTerminatedN/AN/ABoth3N/AFrance
184EUCTR2013-004468-69-HU
(EUCTR)
11/06/201421/02/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia
185EUCTR2013-000830-37-PL
(EUCTR)
11/06/201403/01/2014Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
189Phase 3Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of
186NCT02092077
(ClinicalTrials.gov)
April 30, 201414/3/2014A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient ChildrenA Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient ChildrenGrowth Hormone-DeficiencyDrug: TV-1106;Drug: somatropinTeva Pharmaceutical Industries, Ltd.NULLTerminated3 Years11 YearsAll65Phase 2Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia
187NCT02068521
(ClinicalTrials.gov)
March 3, 20146/2/2014Versartis Long-Term Safety Study of SomavaratanAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.NULLTerminated3 YearsN/AAll385Phase 2/Phase 3United States
188EUCTR2011-001826-61-BG
(EUCTR)
07/02/201412/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
189EUCTR2013-000830-37-NL
(EUCTR)
02/01/201429/07/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
189Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany
190EUCTR2013-000013-20-ES
(EUCTR)
02/01/201410/01/2014A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Phase 1France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden
191NCT02507245
(ClinicalTrials.gov)
January 20143/6/2015Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD)Growth Hormone DeficiencyDrug: Growth Hormone-Releasing HormoneStefania La Grutta, MDNULLCompleted5 Years15 YearsBoth48N/ANULL
192EUCTR2013-000013-20-SE
(EUCTR)
20/12/201312/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
193EUCTR2013-000013-20-BE
(EUCTR)
17/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
194EUCTR2013-000013-20-AT
(EUCTR)
16/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
195NCT01973244
(ClinicalTrials.gov)
December 16, 201322/10/2013A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone DeficiencyA Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years13 YearsAll32Phase 1Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland
196EUCTR2013-000013-20-SI
(EUCTR)
09/12/201320/09/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
197EUCTR2013-000830-37-ES
(EUCTR)
12/10/201312/07/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
PROLOR Biotech Ltd.NULLNot Recruiting Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany
198EUCTR2013-000830-37-GB
(EUCTR)
30/09/201309/07/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
190Phase 3United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Armenia;Poland;Romania;Australia;Georgia;Germany;Netherlands;Korea, Republic of
199EUCTR2013-000830-37-GR
(EUCTR)
12/09/201303/07/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
PROLOR Biotech Ltd.NULLNot RecruitingFemale: yes
Male: yes
189Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Romania;Germany;Netherlands
200EUCTR2012-002787-27-BG
(EUCTR)
11/09/201303/06/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone (rhGH)
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany
201EUCTR2012-004975-37-SE
(EUCTR)
05/09/201309/07/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden
202EUCTR2013-000830-37-SK
(EUCTR)
04/09/201324/05/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
189Phase 3United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of
203EUCTR2013-000830-37-AT
(EUCTR)
29/08/201311/07/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
190Phase 3Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of
204EUCTR2012-004975-37-DE
(EUCTR)
05/08/201302/05/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
205EUCTR2012-002787-27-SI
(EUCTR)
10/07/201310/07/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone (rhGH)
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany
206EUCTR2013-000830-37-HU
(EUCTR)
03/07/201323/05/2013Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency Adult or childhood onset growth hormone deficiency (GHD)
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: na
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
189Phase 3Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of
207NCT01947907
(ClinicalTrials.gov)
July 20133/6/2013Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone Deficiency (GHD)Drug: ACP-001;Drug: Human Growth HormoneAscendis Pharma A/SNULLCompleted3 Years12 YearsAll53Phase 2Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine
208EUCTR2012-004975-37-CZ
(EUCTR)
20/06/201304/01/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
209EUCTR2012-002787-27-DE
(EUCTR)
17/06/201319/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone (rhGH)
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
210NCT01806298
(ClinicalTrials.gov)
June 20135/3/2013An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: Saizen® solution for injection (referred as Saizen®)Merck KGaANULLCompleted18 Years65 YearsAll78Phase 4Australia;Germany;Sweden;United Kingdom;Czech Republic
211NCT01909479
(ClinicalTrials.gov)
June 201324/7/2013A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting Hgh Product (Mod-4023) In Adult Subjects With Growth Hormone DeficiencyA PHASE 3, MULTICENTER STUDY DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF A LONG ACTING HGH PRODUCT (MOD-4023) IN ADULT SUBJECTS WITH GROWTH HORMONE DEFICIENCYAdult Growth Hormone DeficiencyDrug: MOD-4023;Other: PlaceboOPKO Health, Inc.NULLTerminated23 Years70 YearsAll189Phase 3Israel;United States
212EUCTR2012-004975-37-SI
(EUCTR)
22/05/201317/04/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden
213EUCTR2012-005066-36-NL
(EUCTR)
15/05/201323/01/2013To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiencyEffect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Genotropin
Trade Name: Norditropin
Trade Name: Humatrope
Trade Name: Zomacton
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
214EUCTR2012-004263-47-CZ
(EUCTR)
13/05/201305/03/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
215EUCTR2012-002787-27-CZ
(EUCTR)
10/05/201319/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone (rhGH)
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
216NCT01877512
(ClinicalTrials.gov)
May 201311/6/2013GH and Cardiovascular Risk FactorsEffect of Growth Hormone Replacement Therapy on Cardiovascular Risk Factors in Adult Patients With Severe Growth Hormone Deficiency: Association With IGF-I ConcentrationGrowth Hormone Deficiency;Cardiovascular Diseases;Metabolic Syndrome;Cognition;Physical ActivityDrug: Change in daily dosage of Growth HormoneVU University Medical CenterNULLCompleted20 Years65 YearsBoth32Phase 4Netherlands
217EUCTR2012-004263-47-DE
(EUCTR)
03/04/201325/02/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
218EUCTR2011-004553-60-PL
(EUCTR)
02/04/201309/02/2012A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: no INN available yet
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: no INN available yet
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
219NCT01811576
(ClinicalTrials.gov)
March 31, 201312/3/2013A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone DeficiencyA 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: Recombinant human growth hormoneTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted23 Years65 YearsAll52Phase 2United States;Czechia;Germany;Greece;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic;Sweden
220EUCTR2012-004975-37-GR
(EUCTR)
27/03/201329/03/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden
221EUCTR2012-004263-47-SE
(EUCTR)
06/03/201314/01/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZENMerck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
222EUCTR2012-002787-27-GR
(EUCTR)
04/03/201315/02/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
223EUCTR2012-004263-47-GB
(EUCTR)
01/03/201308/01/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZENMerck KGaANULLNot Recruiting Female: yes
Male: yes
77 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesCzech Republic;Australia;Germany;United Kingdom;Sweden
224NCT01494779
(ClinicalTrials.gov)
March 201328/11/2011Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.GH Deficiency (GHD);Growth RetardationDrug: SomatropinL.A.L Clinica Pesquisa e Desenvolvimento Ltda.NULLNot yet recruiting18 Years32 YearsMale32Phase 1Brazil
225EUCTR2012-004975-37-SK
(EUCTR)
27/02/201304/03/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
226EUCTR2012-002787-27-HU
(EUCTR)
11/02/201311/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: somatropin
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone (rhGH)
Product Code: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany
227NCT02500316
(ClinicalTrials.gov)
February 201312/7/2015Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenSafety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient ChildrenGrowth Hormone Deficiency (GHD)Drug: MOD-4023OPKO Health, Inc.NULLActive, not recruiting3 Years11 YearsAll48Phase 2United States;Belarus;Greece;Hungary;Russian Federation;Ukraine;Slovakia
228EUCTR2012-004975-37-HU
(EUCTR)
21/01/201323/11/2012A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden
229NCT01775358
(ClinicalTrials.gov)
January 201317/1/2013Phase 1 Safety Study of ALRN-5281 in Healthy SubjectsA Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult VolunteersGrowth Hormone DeficiencyDrug: ALRN-5281 0.015 mg/kg;Drug: ALRN-5281 0.05 mg/kg;Drug: ALRN-5281 0.15 mg/kg;Drug: Placebo 0.015 mg/kg;Drug: Placebo 0.05mg/kg;Drug: Placebo 0.15mg/kgAileron TherapeuticsNULLCompleted20 Years50 YearsBoth33Phase 1United States
230NCT01731028
(ClinicalTrials.gov)
January 201316/11/2012Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical PracticeGrowth Hormone DeficiencyDrug: SomatropinFerring PharmaceuticalsNULLWithdrawn3 Years18 YearsBoth0N/ANULL
231NCT01901666
(ClinicalTrials.gov)
January 201329/6/2013Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In RemissionASSESSMENT OF GH-IGF1 AXIS AND TO STUDY RESPONSE TO GH THERAPY IN CHILDREN WITH CML IN REMISSION HAVING GH DEFICIENCYChronic Myelogenous Leukemia;Short StatureDrug: Growth HormonePostgraduate Institute of Medical Education and ResearchNULLRecruitingN/AN/ABoth20Phase 4India
232NCT01706783
(ClinicalTrials.gov)
October 12, 201211/10/2012A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone DeficiencyA Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: Norditropin NordiFlex®Novo Nordisk A/SNULLCompleted20 Years70 YearsAll35Phase 1Denmark;Sweden
233NCT01718041
(ClinicalTrials.gov)
October 201219/10/2012Versartis Trial in Children to Assess Long-Acting Growth HormoneA Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children With Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy After Subcutaneous Administration for 6 MonthsPediatric Growth Hormone DeficiencyDrug: Experimental: VRS-317Versartis Inc.NULLCompleted3 Years11 YearsBoth64Phase 1/Phase 2United States
234EUCTR2011-005377-23-ES
(EUCTR)
18/07/201221/05/2012Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). Spinal Cord Injury and Growth Hormone Deficiency
MedDRA version: 14.1;Level: PT;Classification code 10041558;Term: Spinal cord injury thoracic;System Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1;Classification code 10041554;Term: Spinal cord injury cervical;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Trade Name: NUTROPIN
Product Name: NutropinAq 10 mg/2 ml (30 UI)
INN or Proposed INN: SOMATROPIN
Guillem Cuatrecasas CambraNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
235EUCTR2011-004553-60-BG
(EUCTR)
02/07/201210/04/2012A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available yet
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available yet
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
OPKO Biologics Ltd.NULLNot RecruitingFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
236EUCTR2011-004553-60-CZ
(EUCTR)
10/04/201206/12/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available yet
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available yet
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
PROLOR Biotech Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
237NCT01592500
(ClinicalTrials.gov)
February 20122/5/2012Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenSafety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOPKO Health, Inc.NULLCompleted3 Years11 YearsAll56Phase 2Greece;Hungary;Slovakia
238EUCTR2011-001826-61-PL
(EUCTR)
25/01/201212/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
239EUCTR2011-004553-60-GR
(EUCTR)
23/01/201227/12/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
PROLOR Biotech Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel
240NCT01514500
(ClinicalTrials.gov)
January 16, 201213/1/2012First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsFirst Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;HealthyDrug: somapacitan;Drug: placebo (somapacitan)Novo Nordisk A/SNULLCompleted20 Years45 YearsMale105Phase 1Germany
241EUCTR2011-004553-60-HU
(EUCTR)
10/01/201203/11/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: not available
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 2Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation
242EUCTR2011-004553-60-SK
(EUCTR)
10/01/201224/11/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children Pediatric Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: Not available yet
Product Name: n/a
Product Code: MOD-4023
INN or Proposed INN: Not available yet
Trade Name: Genotropin
Product Name: Recombinant human Growth Hormone
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
243NCT01822340
(ClinicalTrials.gov)
October 201125/3/2013Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency PatientsA Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: HM10560A;Drug: GenotropinHanmi Pharmaceutical Company LimitedNULLCompleted23 Years60 YearsBoth72Phase 2Hungary;Romania
244NCT01440686
(ClinicalTrials.gov)
September 201123/9/2011Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male VolunteersA Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male VolunteersGrowth Hormone DeficiencyDrug: Somatropin;Drug: PlaceboHanAll BioPharma Co., Ltd.NULLCompleted19 Years50 YearsMale40Phase 1Korea, Republic of
245EUCTR2011-000460-10-CZ
(EUCTR)
22/08/201122/06/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study Idiopathic Growth Hormone Deficiency and Turner Syndrome
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Saizen 8mg click.easy powder for solution for injection
Product Name: NA
Product Code: NA
INN or Proposed INN: somatropin
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Merck Serono S.A. GenevaNULLNot RecruitingFemale: yes
Male: yes
395Phase 4France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy
246EUCTR2011-000460-10-ES
(EUCTR)
16/08/201121/06/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study Idiopathic Growth Hormone Deficiency and Turner Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.0;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Saizen 8mg click.easy power for solution for injection
Product Name: NA
Product Code: NA
INN or Proposed INN: somatropin
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Merck Serono S.A. GenevaNULLNot RecruitingFemale: yes
Male: yes
395Phase 4France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy
247EUCTR2011-000460-10-GB
(EUCTR)
03/08/201117/05/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study idiopathic growth hormone deficientyTurner Syndrome
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Saizen 8mg click.easy powder for solution for injection
Product Name: Saizen 8mg click.easy powder for solution for injection
Product Code: NA
INN or Proposed INN: somatropin
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
395Phase 4Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom
248EUCTR2011-001826-61-HU
(EUCTR)
29/07/201123/05/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
249NCT01237041
(ClinicalTrials.gov)
July 1, 20116/11/2010Free Fatty Acids, Body Weight, and Growth Hormones Secretion in ChildrenFree Fatty Acids, Body Weight, and Growth Hormone Secretion in ChildrenObesity;Short Stature;Growth Hormone DeficiencyDrug: Niacin First;Drug: Placebo First;Drug: Dose-Establishing Study 1 Niacin 250mg;Drug: Dose-Establishing Study 1 Niacin 500mg;Drug: Dose-Establishing Study 2 Niacin 500mgEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLTerminated7 Years14 YearsAll37Phase 1/Phase 2United States
250EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
251EUCTR2010-020742-10-ES
(EUCTR)
01/04/201107/01/2011Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplicaTratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Finland;United Kingdom;Spain;Sweden
252NCT01327924
(ClinicalTrials.gov)
April 201131/3/2011Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth HormoneEase of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily LifeGrowth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Delivery SystemsDrug: Norditropin NordiFlex®Novo Nordisk A/SNULLCompletedN/A16 YearsBoth77N/AFrance
253EUCTR2010-023430-23-GB
(EUCTR)
28/03/201124/01/2011A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;Czech Republic;United Kingdom
254NCT01804413
(ClinicalTrials.gov)
March 201118/2/2013Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone DeficiencyEffects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot StudyAdults Growth Hormone Deficiency.Drug: Pegvisomant;Drug: Regular insulinOregon Health and Science UniversityAarhus University HospitalRecruiting21 Years55 YearsBoth10N/AUnited States
255NCT01359488
(ClinicalTrials.gov)
March 201113/5/2011VRS-317 in Adult Subjects With Growth Hormone DeficiencyA Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: VRS-317Versartis Inc.NULLCompleted25 Years65 YearsBoth50Phase 1United States
256EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
257EUCTR2010-019374-32-AT
(EUCTR)
15/02/201129/12/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Only medicinal products registered in Austria will be used in this clinical trial.
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany
258EUCTR2010-023430-23-CZ
(EUCTR)
09/02/201125/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
259EUCTR2010-023430-23-HU
(EUCTR)
17/01/201110/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
260EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
261NCT01282164
(ClinicalTrials.gov)
January 201119/1/2011The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic AxisThe Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal AxisAdult Growth Hormone Deficiency;Hypothalamic-pituitary DisordersProcedure: Glucagon stimulation test and insulin tolerance test;Procedure: glucagon stimulation test and insulin tolerance testThe Cleveland ClinicMassachusetts General Hospital;Allegheny Endocrinology Associates;Oregon Health and Science UniversityCompleted18 Years80 YearsAll43N/AUnited States
262EUCTR2009-017354-12-GB
(EUCTR)
08/11/201018/06/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden
263NCT01247675
(ClinicalTrials.gov)
November 201023/11/2010A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone DeficiencyA Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyDrug: ACP-001 (TransCon hGH);Drug: OmnitropeAscendis Pharma A/SNULLCompleted20 Years70 YearsAll37Phase 2Denmark;Germany;Italy;Sweden
264NCT01243892
(ClinicalTrials.gov)
November 201017/11/2010A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin DeviceA Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®Growth Hormone DeficiencyDevice: NuSpin;Drug: SomatropinGenentech, Inc.NULLTerminated2 Years14 YearsAll18Phase 4United States
265EUCTR2009-017354-12-SE
(EUCTR)
11/10/201009/04/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Czech Republic;Sweden
266EUCTR2010-021523-28-DE
(EUCTR)
05/10/201010/08/2010A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
267NCT01090778
(ClinicalTrials.gov)
October 201022/3/2010Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Norditropin SimpleXx (growth hormone)Aarhus University HospitalNovo Nordisk A/SCompleted18 Years75 YearsBoth8Phase 2Denmark
268NCT01237340
(ClinicalTrials.gov)
October 20105/11/2010Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity StudyA Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)Growth Hormone Deficiency (GHD)Drug: Saizen®EMD SeronoNULLTerminated18 Years60 YearsAll59Phase 3United States
269EUCTR2010-021523-28-IT
(EUCTR)
28/09/201027/12/2010A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - NDA phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND Growth Hormone Deficiency
MedDRA version: 9.1;Level: PT;Classification code 10056438
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: OMNITROPE
INN or Proposed INN: Somatropin
ASCENDIS PHARMA A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Germany;Denmark;Italy;Austria;Sweden
270EUCTR2010-021523-28-SE
(EUCTR)
27/09/201006/08/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
271EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
272EUCTR2010-021523-28-DK
(EUCTR)
13/09/201029/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Austria;Denmark;Germany;Italy;Sweden
273EUCTR2010-019374-32-SI
(EUCTR)
13/09/201004/06/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Omnitrop
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: ecombinanat DNA-derived human growth h
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
274EUCTR2010-019374-32-CZ
(EUCTR)
06/09/201015/06/2010A study with MOD-4023 in patients with lack of Growth Hormone in the bodyA Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: n/a
Product Code: MOD-4023
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Prolor Biotech LtdNULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel
275EUCTR2010-021523-28-AT
(EUCTR)
02/09/201020/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
276NCT01225666
(ClinicalTrials.gov)
August 201019/10/2010MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)Adult Growth Hormone DeficiencyDrug: MOD-4023OPKO Health, Inc.NULLCompleted23 Years60 YearsAll52Phase 2Czechia;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic
277EUCTR2009-017354-12-DE
(EUCTR)
29/07/201008/06/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Czech Republic;Germany;Sweden
278EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
279EUCTR2009-017354-12-CZ
(EUCTR)
22/06/201014/04/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Czech Republic;Sweden
280EUCTR2010-019735-35-FR
(EUCTR)
14/06/201030/04/2010Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânienEffets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien Déficit somatotrope de l'adulte consécutif à un traumatisme crânien
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Nutropin Aq
Product Name: NutropinAq
CHU AmiensNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
281EUCTR2009-017354-12-SK
(EUCTR)
09/06/201026/05/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin 5.3 mg in injection system Genotropin pen
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin 12 mg
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Czech Republic;Slovakia;Germany;United Kingdom;Sweden
282EUCTR2010-018586-39-DK
(EUCTR)
01/06/201012/05/2010Diurnal variation of exogenous peptides - Gh Puls/Jurgita IDiurnal variation of exogenous peptides - Gh Puls/Jurgita I Adults with growth hormone disease (AGHD).Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml
Other descriptive name: GROWTH HORMONE
Medical Department M (Endocrinology & Diabetes)NULLNot RecruitingFemale: yes
Male: yes
8Phase 2Denmark
283EUCTR2010-019296-30-GB
(EUCTR)
18/05/201016/04/2010A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1 ALS (acid label subunit) deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth Hormone Deficiency
Trade Name: INCRELEX
Product Name: Increlex
University Hospital Birmingham NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
284NCT01613573
(ClinicalTrials.gov)
March 20101/6/2012Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenA Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenGrowth Hormone DeficiencyDrug: somatropin AQ;Drug: pegylated somatropinGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and TechnologyCompleted4 Years10 YearsMale12Phase 1NULL
285EUCTR2009-016783-37-SE
(EUCTR)
07/01/201016/10/2009The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GHThe Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH Growth hormone deficiency in adultsProduct Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
INN or Proposed INN: recombinant human growth hormone
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
286NCT00884000
(ClinicalTrials.gov)
January 201017/4/2009A Study of Zomacton in Children With Growth Hormone DeficiencyA Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Genotropin;Drug: ZomactonFerring PharmaceuticalsNULLCompleted3 Years11 YearsBoth165Phase 3Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine
287NCT01605331
(ClinicalTrials.gov)
December 200922/5/2012Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)Growth Hormone DeficiencyDrug: sustained-release recombinant human GH (SR-rhGH)LG Life SciencesNULLCompleted20 YearsN/ABoth132Phase 4NULL
288EUCTR2008-008240-25-ES
(EUCTR)
04/11/200910/08/2009Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient childrenEnsayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Slovenia;Belgium;Spain;Denmark;United Kingdom
289NCT01007071
(ClinicalTrials.gov)
November 1, 200930/10/2009Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone DeficiencyEffects of Growth Hormone on Cognition and Cerebral Metabolism in AdultsHypopituitarismDrug: Human Growth Hormone (1-134);Drug: PlaceboStanford UniversityGenentech, Inc.Completed18 Years65 YearsAll11Phase 3United States
290EUCTR2008-008240-25-DK
(EUCTR)
12/10/200917/08/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Slovenia;Denmark;France;Spain
291EUCTR2008-008240-25-GB
(EUCTR)
01/10/200918/06/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain
292NCT01109017
(ClinicalTrials.gov)
October 200919/4/2010Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone DeficiencyA Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHDGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth387N/AJapan
293EUCTR2008-008240-25-FR
(EUCTR)
02/09/200910/04/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
6Phase 2France;Slovenia;Spain;Belgium;Denmark;United Kingdom
294EUCTR2009-010918-30-IE
(EUCTR)
11/08/200911/03/2009Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care.
MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism
MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism
MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency
MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma
MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma
MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease
MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour
MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign
Trade Name: Genotropin 5.3mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin 12mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.4mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.6mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.8mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.0mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniqu
Amar Agha, Beaumont HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Ireland
295NCT00936403
(ClinicalTrials.gov)
August 20099/7/2009A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth HormoneA Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient ChildrenGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: NNC126-0083;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years12 YearsAll31Phase 2Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom
296EUCTR2008-004849-28-HU
(EUCTR)
09/07/200903/06/2009A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency - Idiopathic growth hormone deficiency.
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Zomacton 10 mg/ml
INN or Proposed INN: Somatropin
Trade Name: Genotropin 12 mg/ml
INN or Proposed INN: Somatropin
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
138Hungary
297NCT00934063
(ClinicalTrials.gov)
July 20092/7/2009An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)Growth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Other: No treatment givenNovo Nordisk A/SNULLCompleted18 YearsN/ABoth121N/AGermany
298EUCTR2008-008240-25-BE
(EUCTR)
10/06/200924/04/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32France;Slovenia;Spain;Belgium;Denmark;United Kingdom
299EUCTR2008-008240-25-SI
(EUCTR)
25/05/200906/05/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain
300EUCTR2008-001674-32-FI
(EUCTR)
29/04/200925/08/2008NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOSNordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency
MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
Trade Name: Norditropin
INN or Proposed INN: somatotropine
Novo Nordisk Farma OyNULLNot RecruitingFemale: yes
Male: yes
17000Phase 4Finland
301NCT00837863
(ClinicalTrials.gov)
March 20092/2/2009Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone DeficiencyA Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomatropinAltus PharmaceuticalsNULLRecruiting3 Years13 YearsBoth36Phase 2United States
302NCT01298180
(ClinicalTrials.gov)
January 20096/11/2009Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Prader-Willi Syndrome;Growth Hormone DeficiencyDrug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsyUniversity Hospital, ToulouseNULLCompleted1 Year5 YearsAll111Phase 4France
303EUCTR2007-001746-40-HU
(EUCTR)
25/08/200802/04/2007A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: ARX201
Other descriptive name: Pegylated recombinant human growth hormone
Ambrx, Inc., USANULLNot RecruitingFemale: yes
Male: yes
45Phase 2Hungary
304NCT00778518
(ClinicalTrials.gov)
July 200822/10/2008Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).Growth Hormone DeficiencyDrug: ARX201Ambrx, Inc.Merck Serono International SACompleted18 Years30 YearsMale36Phase 2Hungary
305NCT00675506
(ClinicalTrials.gov)
July 20087/5/2008Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are ObesePhysiologic Effects of Long-Term GHRH1-44 in Abdominal ObesityAbdominal Obesity;Growth Hormone DeficiencyDrug: Growth hormone releasing hormone (GHRH) 1-44;Drug: PlaceboMassachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Completed18 Years55 YearsAll60Phase 2United States
306NCT00715689
(ClinicalTrials.gov)
July 200814/7/2008Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)Growth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: NNC126-0083;Drug: placeboNovo Nordisk A/SNULLCompleted20 Years65 YearsAll33Phase 2Denmark
307EUCTR2008-001061-29-DK
(EUCTR)
17/06/200829/04/2008A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) Growth hormone deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: NN8630
Product Code: NNC 126-0083
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Denmark
308NCT00630487
(ClinicalTrials.gov)
May 200828/2/2008Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone DeficiencyProspective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)Growth Hormone DeficiencyDrug: Placebo;Drug: SomatropinPfizerNULLTerminated18 Years65 YearsAll9Phase 3Germany
309EUCTR2007-003586-41-IT
(EUCTR)
04/03/200801/07/2008PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - NDPLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND Growth hormone deficiency (GHD)after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: GenotropinPFIZERNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
310NCT00555009
(ClinicalTrials.gov)
March 200824/10/2007Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain InjuryPlacebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.Brain Injuries;Growth Hormone DeficiencyDrug: Genotropin;Drug: PlaceboPfizerNULLTerminated18 Years55 YearsAll10Phase 4France;Italy;Netherlands;Spain;Sweden;United Kingdom
311NCT00646815
(ClinicalTrials.gov)
March 200819/2/2008Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyInsulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (genotropin)University of AarhusAarhus University HospitalCompleted18 Years60 YearsBoth24N/ADenmark
312EUCTR2007-003586-41-FR
(EUCTR)
13/02/200814/11/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin/GENOTONORM®
Product Name: Genotropin/GENOTONORM®
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
313EUCTR2007-000790-36-DE
(EUCTR)
08/01/200812/12/2007Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD StudyProspective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study Isolated Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin 5 mg/ml
INN or Proposed INN: Somatropin
Trade Name: Genotropin 5 mg/ml
INN or Proposed INN: Somatropin
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
50Germany
314NCT00684957
(ClinicalTrials.gov)
January 200823/5/2008Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk FactorsDifferential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1Columbia UniversityTercicaTerminated25 Years65 YearsMale5N/AUnited States
315EUCTR2007-003586-41-NL
(EUCTR)
17/12/200709/08/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
316NCT01365351
(ClinicalTrials.gov)
December 1, 20071/6/2011Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTONNon-interventional Study With ZOMACTON in Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyOther: Growth hormoneFerring PharmaceuticalsFerring Arzneimittel GmbHCompletedN/AN/AAll1034N/AGermany
317EUCTR2005-005587-82-GR
(EUCTR)
28/11/200728/06/2007A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LtdNULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
318EUCTR2007-003586-41-ES
(EUCTR)
26/11/200720/11/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A Tratamiento del déficit de hormona de crecimiento en adultos después de un traumatismo cerebral.
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (Marca internacional Genotropin)
Product Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para sol. inyectable (Marca internacional Genotropin)
INN or Proposed INN: Somatropina
Pfizer, S.ANULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;Spain;Netherlands;Italy;United Kingdom;Sweden
319EUCTR2007-003586-41-SE
(EUCTR)
21/11/200712/09/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
320EUCTR2007-003586-41-GB
(EUCTR)
15/11/200711/10/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
321NCT01306357
(ClinicalTrials.gov)
September 200728/2/2011Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free DeviceEvaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale ProspectiveTurner's Syndrome;Human Growth Hormone DeficiencyDrug: SomatropinFerring PharmaceuticalsNULLCompletedN/AN/ABoth87N/AFrance
322EUCTR2006-003678-82-NL
(EUCTR)
10/07/200702/04/2008Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiencyPharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency Clonidine is studied in the paediatric population, more specific children with short stature. It is used as a diagnostic tool to establish Growth Hormone reserve in routine practice.
MedDRA version: 8.1;Level: LLT;Classification code 10005573;Term: Blood growth hormone decreased
Trade Name: CatapresanCentre for Human Drug ResearchNULLNot RecruitingFemale: yes
Male: yes
Netherlands
323EUCTR2005-005587-82-PL
(EUCTR)
07/07/200731/05/2007A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LtdNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Czech Republic;Greece;Belgium;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
324NCT00491582
(ClinicalTrials.gov)
July 200725/6/2007The Effects of Growth Hormone (GH) on Lipid DepotsThe Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin ResistanceGrowth Hormone DeficiencyDrug: Growth hormone replacement therapy in growth hormone deficient patients only.University Hospital Inselspital, BerneSwiss National Science FoundationCompleted18 Years80 YearsBoth34N/ASwitzerland
325NCT00324064
(ClinicalTrials.gov)
July 20078/5/2006Sexually Dimorphic Effects of GHRH in Adult Growth Hormone TestingSexually Dimorphic Effects of GHRH in Adult Growth Hormone TestingGrowth Hormone DeficiencyProcedure: GHRH/arginine stimulation testingChildren's Mercy Hospital Kansas CityNULLCompleted5 Years40 YearsBoth90N/AUnited States
326NCT00448747
(ClinicalTrials.gov)
June 200716/3/2007Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and EfficacyDiagnosis of Adult Growth Hormone Deficiency (AGDH)Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRHAEterna ZentarisNULLCompleted18 YearsN/AAll101Phase 3United States
327EUCTR2006-002278-24-SE
(EUCTR)
15/05/200705/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
328EUCTR2006-002278-24-GB
(EUCTR)
02/05/200723/11/2006 A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
329NCT00615953
(ClinicalTrials.gov)
May 20073/2/2008American Norditropin Studies - Registry of Growth Hormone (GH) PatientsAmerican Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149Growth Hormone DeficiencyDrug: Norditropin Growth HormoneDuke UniversityNovo Nordisk A/SSuspendedN/AN/ABoth79N/AUnited States
330EUCTR2006-002278-24-SK
(EUCTR)
20/04/200722/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
331EUCTR2006-002278-24-FR
(EUCTR)
13/04/200724/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
332EUCTR2006-002278-24-IT
(EUCTR)
05/04/200716/12/2008A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-ROA phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO Growth hormone deficiency
MedDRA version: 9.1;Level: HLT;Classification code 10002701;Term: Anterior pituitary hypofunction
Product Name: LB03002
INN or Proposed INN: sustained release growth hormone
BIOPARTNERS GMBHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
333NCT00432263
(ClinicalTrials.gov)
April 20075/2/2007Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain InjuryBrain InjuriesDrug: Genotropin (PN-180,307) SomatropinPfizerNULLWithdrawn18 Years55 YearsBoth0Phase 4NULL
334NCT00455260
(ClinicalTrials.gov)
April 20072/4/2007A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-DeficiencyA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ SystemTeva Neuroscience, Inc.Teva Pharmaceutical Industries;TransPharma MedicalCompleted20 Years60 YearsBoth60Phase 1Israel;Ukraine
335NCT01495468
(ClinicalTrials.gov)
March 200716/12/2011Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenPegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical TrialGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin UniversityCompleted8 Years15 YearsAll343Phase 3China
336NCT00601419
(ClinicalTrials.gov)
March 200715/1/2008Drug Use Investigation of Somatropin for GHD-ADULTS.Drug Use Investigation of GENOTROPIN for GHD-ADULTS.Dwarfism, Growth Hormone DeficiencyDrug: SomatropinPfizerNULLCompletedN/AN/AAll230N/ANULL
337NCT01187550
(ClinicalTrials.gov)
March 200722/8/2010Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®Dwarfism, PituitaryDrug: Recombinant human growth hormone (r-hGH)Merck KGaAMerck Serono Co., Ltd., ChinaCompletedN/AN/AAll214Phase 4NULL
338EUCTR2005-005587-82-CZ
(EUCTR)
15/02/200725/10/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Netherlands;Denmark;Italy;Greece;Poland;Sweden
339NCT00720902
(ClinicalTrials.gov)
February 200716/6/2008Adult Growth Hormone Deficiency and Cardiovascular RiskAssessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary AdenomasGrowth Hormone DeficiencyProcedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsyColumbia UniversityNULLTerminated19 Years65 YearsBoth8N/AUnited States
340EUCTR2006-005442-37-NL
(EUCTR)
08/01/200702/11/2006PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injuryPITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury isolated growth hormone deficiency after traumatic brain injuryTrade Name: recombinant growth hormoneUniversity Medical Center St Radboud, department of neurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
341EUCTR2006-002278-24-AT
(EUCTR)
05/01/200710/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
342NCT01576861
(ClinicalTrials.gov)
January 200719/3/2012Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart FailureGrowth Hormone Deficiency;Chronic Heart FailureDrug: SomatotropinFederico II UniversityNULLCompleted18 Years80 YearsBoth28Phase 2Italy
343EUCTR2005-000346-36-LT
(EUCTR)
29/12/200624/10/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania
344EUCTR2006-002278-24-CZ
(EUCTR)
14/12/200608/09/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
345EUCTR2006-002278-24-ES
(EUCTR)
13/12/200610/03/2010Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
346EUCTR2006-001574-24-NL
(EUCTR)
06/10/200615/06/2006Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteriesTrade Name: Genotropin
Product Name: genotropin
Product Code: RVG 15790 or RVG 25480
Radboud University Nijmegen Medical Centre, Department of EndocrinologyNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
347EUCTR2006-002278-24-DE
(EUCTR)
06/10/200615/08/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
348EUCTR2005-004316-73-GB
(EUCTR)
23/08/200612/12/2005The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivityThe effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan)Product Name: strontium ranelate
Product Code: strontium ranelate
INN or Proposed INN: strontium ranelate
Other descriptive name: N/A
Product Name: Phosphate sandoz
Product Code: phosphate sandoz
INN or Proposed INN: phosphate sandoz
Other descriptive name: N/A
Product Name: growth hormone
Product Code: growth hormone
INN or Proposed INN: growth hormone
Other descriptive name: N/A
Royal Liverpool University hospitalNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
349EUCTR2005-005587-82-NL
(EUCTR)
08/08/200612/05/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
PfizerPfizerNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
350EUCTR2005-005587-82-IT
(EUCTR)
02/08/200623/06/2006A DOUBLE BLIND PARALLEL GROUP RANDOMISED MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMIC RESPONSE AND SAFETY OF PHA-794428 IN ADULT GROWTH HORMONE DEFICIENT PATIENTS - NDA DOUBLE BLIND PARALLEL GROUP RANDOMISED MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMIC RESPONSE AND SAFETY OF PHA-794428 IN ADULT GROWTH HORMONE DEFICIENT PATIENTS - ND Adult growth hormone deficiency AGHD .
MedDRA version: 6.1;Level: PT;Classification code 10056438
Product Code: PHA-794,428
Product Code: PHA-794,428
PFIZERNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
351NCT00596037
(ClinicalTrials.gov)
August 20067/1/2008Treatment of Adults With Growth Hormone DeficiencyA Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone DeficiencyPituitary Disorders;Adult Growth Hormone DeficiencyDrug: Growth hormone - LB03002LG Life SciencesBioPartners GmbHCompleted23 Years70 YearsBoth136Phase 3United States
352EUCTR2005-005593-79-BE
(EUCTR)
31/07/200611/05/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer N.V./S.A.NULLNot RecruitingFemale: yes
Male: yes
32Spain;Belgium;Germany;United Kingdom
353EUCTR2005-005587-82-BE
(EUCTR)
03/07/200622/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer NV/SANULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Greece;Poland;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
354NCT00308464
(ClinicalTrials.gov)
July 200627/3/2006A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone DeficiencyA Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient PatientsGrowth Hormone DeficiencyDrug: PHA-794428PfizerNULLTerminated18 Years65 YearsBoth136Phase 2Belgium;Czech Republic;Denmark;France;Germany;Italy;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom
355EUCTR2005-005587-82-DE
(EUCTR)
21/06/200606/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;Greece;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
356EUCTR2005-005587-82-SE
(EUCTR)
12/06/200602/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer AB;Pfizer LtdNot RecruitingFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
357EUCTR2005-005593-79-DE
(EUCTR)
09/06/200603/04/2006A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Germany;Spain
358EUCTR2005-005593-79-GB
(EUCTR)
02/06/200621/03/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
32Germany;United Kingdom;Spain
359EUCTR2005-005593-79-ES
(EUCTR)
31/05/200604/04/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiencyA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Code: PHA-794428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Code: PHA-794428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer SANULLNot RecruitingFemale: yes
Male: yes
32Phase 2Belgium;Spain;Germany;United Kingdom
360EUCTR2005-005587-82-GB
(EUCTR)
17/05/200620/04/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Code: PHA-794,428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Code: PHA-794,428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
136Sweden;Poland;Greece;Italy;Denmark;Netherlands;United Kingdom;Czech Republic
361EUCTR2004-000356-17-FI
(EUCTR)
16/05/200614/03/2006PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
Ipsen ScandinaviaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy
362NCT01342146
(ClinicalTrials.gov)
May 200621/4/2011Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency ChildrenEfficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 StudyGrowth Hormone DeficiencyDrug: pegylated Somatropin;Drug: Jintropin AQGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan UniversityCompletedN/AN/AAll101Phase 2NULL
363EUCTR2005-005587-82-DK
(EUCTR)
26/04/200615/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
364NCT00960128
(ClinicalTrials.gov)
April 1, 200613/8/2009Observational Prospective Study on Patients Treated With Norditropin®NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll21249N/AArgentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro
365NCT00294619
(ClinicalTrials.gov)
April 200620/2/2006Treatment of Adults With Growth Hormone DeficiencyA Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.Pituitary Disorders;Adult Growth Hormone DeficiencyDrug: growth hormoneLG Life SciencesBioPartners GmbHCompleted23 Years70 YearsBoth147Phase 3United States
366NCT00314938
(ClinicalTrials.gov)
April 200613/4/2006A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone DeficiencyA Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: PHA-794428PfizerNULLTerminated6 Years12 YearsBoth32Phase 2Belgium;France;Germany;Israel;United Kingdom;Spain
367EUCTR2005-000384-26-IT
(EUCTR)
23/03/200602/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiencyA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency Growth hormone deficiency in adult
MedDRA version: 6.1;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: Somatropin
BIOPARTNERS GMBHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden
368EUCTR2005-001315-22-AT
(EUCTR)
09/03/200618/01/2006The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age.The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. We plan to study healthy aging subjects.Trade Name: Aricept
Product Name: Aricept
Product Code: Donepezil
Ludwig Boltzmann GesellschaftNULLNot RecruitingFemale: yes
Male: yes
80Austria
369EUCTR2005-004478-26-SE
(EUCTR)
13/01/200628/10/2005Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines.Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours.Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
INN or Proposed INN: somatropin
Karolinska universitetssjukhusetNULLNot RecruitingFemale: yes
Male: yes
Sweden
370NCT00362063
(ClinicalTrials.gov)
January 20068/8/2006304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone DeficiencyEffects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (Nutropin)Baylor College of MedicineGenentech, Inc.Active, not recruiting1 Month17 YearsAll20N/AUnited States
371NCT00517062
(ClinicalTrials.gov)
January 200615/8/2007Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production RatesEffects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient AdultsGrowth Hormone DeficiencyDrug: Growth hormone (Genotropin);Drug: PlaceboOregon Health and Science UniversityNULLCompleted18 Years75 YearsBoth16Phase 0United States
372EUCTR2005-000384-26-DE
(EUCTR)
20/12/200502/06/2006A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;Spain;Sweden
373EUCTR2005-000384-26-AT
(EUCTR)
10/11/200510/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.BioPartnersNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden
374EUCTR2005-000384-26-SK
(EUCTR)
27/10/200519/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
375EUCTR2005-000384-26-GB
(EUCTR)
21/10/200517/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
376EUCTR2004-004292-11-SE
(EUCTR)
06/10/200505/08/2005Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCODiscontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design. Trade Name: Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin)
Product Name: Norditropin SimplexX
Product Code: NA
Endocrine Department, Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
377NCT00139945
(ClinicalTrials.gov)
October 200530/8/2005Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient PatientsEffects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol InteractionHypopituitarismDrug: Human acylated ghrelinUniversity of AarhusNULLCompleted18 Years60 YearsBoth8N/ADenmark
378EUCTR2005-000384-26-CZ
(EUCTR)
30/09/200508/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
379EUCTR2005-000346-36-FI
(EUCTR)
22/09/200530/05/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
380EUCTR2005-000384-26-SE
(EUCTR)
13/09/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
381NCT00271518
(ClinicalTrials.gov)
September 200529/12/2005Treatment of Children With Insufficient Secretion of Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth HormoneGrowth Hormone Deficiency (GHD)Drug: growth hormone (somatropin)LG Life SciencesBioPartners GmbHActive, not recruiting3 Years11 YearsBoth144Phase 3United States
382NCT00149708
(ClinicalTrials.gov)
September 20056/9/2005Consequence of Lifetime Isolated Growth Hormone DeficiencyConsequence of Lifetime Isolated Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone administration for 6 monthsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Genentech, Inc.Completed18 Years80 YearsBoth400N/ABrazil
383EUCTR2005-000384-26-ES
(EUCTR)
22/08/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimientoA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
138Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
384EUCTR2005-000346-36-SE
(EUCTR)
18/08/200516/06/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
385EUCTR2005-000346-36-DE
(EUCTR)
16/08/200506/06/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
386NCT00397319
(ClinicalTrials.gov)
August 20058/11/2006Growth Hormone's Effect on the Cardiovascular SystemThe Role of Growth Hormone in Cardiovascular HealthGrowth Hormone DeficiencyDrug: Growth HormoneVanderbilt UniversityPfizer;National Center for Research Resources (NCRR)Terminated18 Years65 YearsBoth26N/AUnited States
387NCT00297713
(ClinicalTrials.gov)
July 200527/2/2006Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug SafetyA Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug SafetyAdult Growth Hormone DeficiencyDrug: ALTU-238Altus PharmaceuticalsNULLCompleted18 Years60 YearsBoth12Phase 2United States
388EUCTR2005-001658-25-BE
(EUCTR)
16/06/200505/07/2005An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency.An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency. AGHD Adult Growth Hormone DeficiencyProduct Code: PHA-794428
Product Code: PHA-794428
Pfizer Global Research and DevelopmentNULLNot RecruitingFemale: no
Male: yes
8Belgium
389NCT00256126
(ClinicalTrials.gov)
May 31, 200518/11/2005Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®Growth Hormone Deficiency;Turner SyndromeDrug: SaizenMerck KGaA, Darmstadt, GermanyNULLCompleted2 Years16 YearsAll318Phase 4Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom
390NCT00187993
(ClinicalTrials.gov)
May 200512/9/2005Growth Hormone Treatment of Young Growth Hormone-Deficient AdultsGrowth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.Growth Hormone DeficiencyDrug: Growth hormoneUniversity Hospital, AngersNovo Nordisk A/SRecruiting18 Years35 YearsBoth30N/AFrance
391NCT01604161
(ClinicalTrials.gov)
May 200521/5/2012Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner SyndromeA Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth2016N/AJapan
392NCT01351818
(ClinicalTrials.gov)
May 20052/5/2011Adipocyte Function and Somtropin DeficiencyThe Fayds Project: Adipocyte Function and Somtropin DeficiencyGrowth Hormone DeficiencyDrug: Growth HormoneFerring PharmaceuticalsFerring SAUCompleted5 Years12 YearsBoth62N/ASpain
393EUCTR2004-000356-17-DK
(EUCTR)
19/04/200529/11/2004PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy
394EUCTR2004-000356-17-AT
(EUCTR)
12/03/200502/05/2005Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - OptimaPhase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq(tm) is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Austria;Italy
395EUCTR2004-004835-72-GB
(EUCTR)
12/01/200517/02/2005A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) Growth hormone deficiency in adult lifeTrade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx 5mg/1.5ml
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone, GH
University of BirminghamUniversity Hospital Birmingham Foundation NHS TrustNot RecruitingFemale: yes
Male: yes
200United Kingdom
396NCT00109733
(ClinicalTrials.gov)
January 20052/5/2005Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone DeficiencyA Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS)Childhood-onset Growth Hormone Deficiency;Pituitary DwarfismBiological: recombinant human growth hormoneEMD SeronoNULLCompleted13 Years25 YearsAll31Phase 3United States
397NCT00163189
(ClinicalTrials.gov)
January 20059/9/2005Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By GenotonormEvolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By GenotonormGrowth Hormone DeficiencyDrug: SomatropinPfizerNULLCompletedN/AN/AAll98Phase 3France
398NCT00212758
(ClinicalTrials.gov)
January 200514/9/2005A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in BloodIGF-1 Generation Test in Children With Chronic Kidney DiseaseKidney Failure, Chronic;Growth Hormone DeficiencyDrug: Nutropin AQOregon Health and Science UniversityGenentech, Inc.Completed2 Years18 YearsAll17Phase 4United States
399NCT00373386
(ClinicalTrials.gov)
January 20057/9/2006Growth Hormone and Endothelial Function in ChildrenGrowth Hormone and Endothelial Function in ChildrenGrowth Hormone Deficiency;Panhypopituitarism;Short StatureDrug: growth hormoneOhio State UniversityNationwide Children's HospitalCompleted8 Years18 YearsBoth12Phase 4United States
400NCT00591760
(ClinicalTrials.gov)
December 200420/12/2007Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary TrialCorrection of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind StudyHeart Failure;Growth Hormone Deficiency;Ischemic Heart DiseaseDrug: SomatotropinFederico II UniversityNULLCompleted18 Years80 Years