Human Growth Hormone ( DrugBank: Growth hormone, Human growth hormone )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
78下垂体前葉機能低下症184
187歌舞伎症候群1
193プラダー・ウィリ症候群3
265脂肪萎縮症12

78. 下垂体前葉機能低下症


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000929-42-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
2EUCTR2020-000929-42-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
3ChiCTR2100048579
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
4EUCTR2020-000929-42-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
5EUCTR2020-000929-42-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
6EUCTR2020-000929-42-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
7EUCTR2020-000929-42-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
8EUCTR2020-000874-92-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
9NCT04633057
(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
10ChiCTR2000039505
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
11NCT04020913
(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
12NCT03775993
(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
13EUCTR2017-003410-20-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
14EUCTR2017-003410-20-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
15EUCTR2017-003410-20-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
16EUCTR2017-003410-20-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
17EUCTR2016-001145-11-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
18EUCTR2016-001145-11-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
19EUCTR2016-001145-11-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
20NCT03145831
(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
21EUCTR2016-001145-11-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
22NCT03075644
(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
23EUCTR2016-002780-34-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
24EUCTR2016-002780-34-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
25NCT02781727
(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
26EUCTR2016-002780-34-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
27EUCTR2015-001939-21-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
28NCT03015909
(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
29EUCTR2015-001939-21-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
30EUCTR2015-001939-21-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
31EUCTR2015-001939-21-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
32EUCTR2014-004525-41-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
33NCT03223025
(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
34NCT03309891
(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
35EUCTR2014-002736-13-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
36EUCTR2014-003796-32-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
37EUCTR2014-002736-13-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
38EUCTR2014-003796-32-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
39EUCTR2014-003796-32-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
40EUCTR2015-001939-21-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
41EUCTR2015-001939-21-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
42EUCTR2014-002736-13-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
43EUCTR2014-003796-32-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
44EUCTR2015-001939-21-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
45EUCTR2005-000384-26-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
46EUCTR2014-003796-32-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
47EUCTR2014-002736-13-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
48EUCTR2014-003796-32-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
49EUCTR2014-004525-41-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
50EUCTR2014-003796-32-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
51EUCTR2014-002736-13-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
52NCT02339090
(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
53EUCTR2014-003796-32-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
54EUCTR2014-002736-13-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
55EUCTR2014-003796-32-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
56EUCTR2014-002736-13-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
57NCT02413138
(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
58EUCTR2014-003796-32-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
59EUCTR2014-002736-13-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
60EUCTR2015-001939-21-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
61EUCTR2014-002698-13-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
62EUCTR2014-002736-13-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
63EUCTR2014-002736-13-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
64EUCTR2014-003796-32-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
65EUCTR2014-003796-32-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
66EUCTR2014-002736-13-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
67EUCTR2014-003796-32-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
68EUCTR2014-002698-13-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
69EUCTR2013-004468-69-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
70EUCTR2014-002736-13-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
71EUCTR2014-003796-32-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
72EUCTR2014-002736-13-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
73EUCTR2014-004525-41-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
74EUCTR2014-004525-41-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
75EUCTR2014-002698-13-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
76EUCTR2013-004468-69-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
77EUCTR2014-002698-13-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
78NCT02382939
(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
79EUCTR2014-002698-13-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
80EUCTR2014-000290-39-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
81EUCTR2013-004468-69-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
82EUCTR2014-000290-39-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
83EUCTR2014-002698-13-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
84NCT02418767
(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
85NCT02946606
(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
86EUCTR2014-000290-39-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
87EUCTR2013-004468-69-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
88EUCTR2013-004468-69-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
89EUCTR2013-004468-69-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
90EUCTR2013-000830-37-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
91NCT02092077
(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
92NCT02068521
(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
93EUCTR2011-001826-61-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
94EUCTR2013-000830-37-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
95EUCTR2013-000830-37-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
96EUCTR2013-000830-37-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
97EUCTR2013-000830-37-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
98EUCTR2012-002787-27-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
99EUCTR2012-004975-37-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
100EUCTR2013-000830-37-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
101EUCTR2013-000830-37-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
102EUCTR2012-004975-37-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
103EUCTR2012-002787-27-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
104EUCTR2013-000830-37-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
105NCT01947907
(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
106EUCTR2012-004975-37-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
107EUCTR2012-002787-27-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
108EUCTR2012-004975-37-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
109EUCTR2012-002787-27-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
110EUCTR2011-004553-60-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
111NCT01811576
(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
112EUCTR2012-004975-37-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
113EUCTR2012-002787-27-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
114EUCTR2012-004975-37-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
115EUCTR2012-002787-27-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
116NCT02500316
(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
117EUCTR2012-004975-37-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
118NCT01718041
(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
119EUCTR2011-004553-60-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
120EUCTR2011-004553-60-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
121EUCTR2011-001826-61-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
122EUCTR2011-004553-60-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
123EUCTR2011-004553-60-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
124EUCTR2011-004553-60-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
125NCT01822340
(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
126EUCTR2011-000460-10-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
127EUCTR2011-000460-10-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
128EUCTR2011-000460-10-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
129EUCTR2011-001826-61-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
130EUCTR2010-019374-32-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
131NCT01237340
(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
132EUCTR2010-019374-32-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
133EUCTR2010-019374-32-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
134EUCTR2010-019374-32-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
135NCT01225666
(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
136EUCTR2010-019374-32-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
137EUCTR2009-016783-37-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
138NCT01605331
(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
139EUCTR2008-008240-25-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
140NCT01007071
(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
141EUCTR2008-008240-25-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
142EUCTR2008-008240-25-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
143EUCTR2008-008240-25-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
144NCT00936403
(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
145EUCTR2008-008240-25-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
146EUCTR2008-008240-25-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
147EUCTR2007-001746-40-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
148EUCTR2008-001061-29-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
149NCT00684957
(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
150NCT01306357
(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
151EUCTR2006-002278-24-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
152EUCTR2006-002278-24-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
153EUCTR2006-002278-24-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
154EUCTR2006-002278-24-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
155NCT01187550
(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
156EUCTR2006-002278-24-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
157EUCTR2005-000346-36-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
158EUCTR2006-002278-24-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
159EUCTR2006-002278-24-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
160EUCTR2006-002278-24-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
161EUCTR2005-000384-26-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
162EUCTR2005-000384-26-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
163EUCTR2005-000384-26-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
164EUCTR2005-000384-26-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
165EUCTR2005-000384-26-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
166EUCTR2005-000346-36-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
167EUCTR2005-000384-26-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
168EUCTR2005-000384-26-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
169EUCTR2005-000346-36-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
170EUCTR2005-000346-36-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
171NCT00297713
(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
172NCT00109733
(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
173NCT00489294
(ClinicalTrials.gov)
August 200419/6/2007Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone DeficiencyAn Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy VolunteersGrowth Hormone DeficiencyDrug: SyntropinPhage Pharmaceuticals, Inc.NULLCompleted18 Years45 YearsBoth20Phase 1United States
174NCT00182091
(ClinicalTrials.gov)
August 200414/9/2005Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone DeficiencyEffects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of AcromegalyAcromegaly;Growth Hormone Deficiency;Pituitary DiseaseDrug: Recombinant human growth hormone;Drug: SalineMassachusetts General HospitalNULLCompleted18 Years85 YearsAll75N/AUnited States
175NCT00929799
(ClinicalTrials.gov)
November 200329/6/2009Growth Hormone and Glucose MetabolismEffects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: recombinant human Growth Hormone (Genotropin® )Charite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth6Phase 4Germany
176NCT00957671
(ClinicalTrials.gov)
November 200310/8/2009Anterior Pituitary Hormone Replacement in Traumatic Brain InjuryAnterior Pituitary Hormone Replacement in Traumatic Brain InjuryGrowth Hormone Deficiency;Traumatic Brain InjuryDrug: Recombinant human growth hormoneThe University of Texas Medical Branch, GalvestonThe Moody FoundationCompleted21 YearsN/AAll15Phase 4United States
177NCT01009905
(ClinicalTrials.gov)
June 24, 20025/11/2009An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth HormoneGrowth Hormone Disorder;Pituitary Dwarfism;HypopituitarismDrug: somatropinNovo Nordisk A/SNULLCompletedN/A18 YearsAll22960N/AUnited States
178NCT00458991
(ClinicalTrials.gov)
June 20019/4/2007rhGH Therapy on Hepatic Drug MetabolismRecombinant Human Growth Hormone Therapy and Drug MetabolismGrowth Hormone Deficiency, DwarfismDrug: Dextromethorphan and CaffeineUniversity of LouisvilleEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed4 Years14 YearsAll9N/AUnited States
179NCT00174278
(ClinicalTrials.gov)
February 19979/9/2005Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature SecondaryTreatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.Growth Hormone Deficiency;Growth RetardationDrug: SomatropinPfizerNULLCompleted6 YearsN/ABoth14Phase 3France
180EUCTR2012-002787-27-FR
(EUCTR)
23/09/2015A 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: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: 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;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
181EUCTR2013-004468-69-RO
(EUCTR)
02/06/2014A 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 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: 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.NULLNAFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
182EUCTR2010-019374-32-DE
(EUCTR)
07/12/2010A 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 Germany 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 2Hungary;Czech Republic;Slovakia;Germany;Slovenia
183EUCTR2016-001145-11-BG
(EUCTR)
11/01/2017A 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: 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
Product Name: TransCon hGH (ACP-011) - 24.2mg
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug
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
184EUCTR2016-000446-56-Outside-EU/EEA
(EUCTR)
07/03/2016Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone.Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. - CERES Growth deficiency due to 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: NA
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: SOMATROPIN
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: NA
Other descriptive name: SOMATROPIN
Cristália Produtos Químicos Farmacêuticos Ltda.NULLNAFemale: yes
Male: yes
94Brazil

187. 歌舞伎症候群


臨床試験数 : 3 薬物数 : 8 - (DrugBank : 2) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000432-26-NL
(EUCTR)
26/09/201227/03/2012Prospective study on the metabolic and linear growth effects of growh hormone treatment in children with Kabuki SyndromeProspective study on the metabolic and linear growth effects of growh hormone treatment in children with Kabuki Syndrome - Metabolic effects of Growth Hormone Kabuki Syndrome (KS, OMIM 147920) with a mutation in MLL2 gene.
;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Maastricht University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100046551
2021-05-182021-05-21Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatmentApplication of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome Prader-Willi sydromePrader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none;Cai JinhuaNULLRecruiting016BothPrader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40;N/AChina
2NCT03554031
(ClinicalTrials.gov)
April 14, 201830/5/2018A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromeA Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Recombinant Human Growth Hormone (rhGH) InjectionGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of MedicineUnknown status1 Month5 YearsAll30Phase 3China
3EUCTR2017-002164-41-ES
(EUCTR)
03/07/201721/06/2017Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures.Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit.
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Genotonorm Miniquick 0,2 mg
INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain

265. 脂肪萎縮症


臨床試験数 : 116 薬物数 : 170 - (DrugBank : 61) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 97
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-003233-16-ES
(EUCTR)
11/12/200722/10/2007A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal.A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal. Lipodistrofia asociada a VIH.HIV-associated lipodystrophy.
MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: Tesamorelin
Product Code: TH9507
INN or Proposed INN: Tesamorelin
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
2EUCTR2007-003233-16-GB
(EUCTR)
29/11/200702/08/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. HIV-associated lipodystrophy
MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: Tesamorelin
Product Code: TH9507
INN or Proposed INN: Tesamorelin
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;United Kingdom
3EUCTR2007-003233-16-FR
(EUCTR)
19/09/200731/07/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. HIV-associated lipodystrophy
MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: Tesamorelin
Product Code: TH9507
INN or Proposed INN: Tesamorelin
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
4EUCTR2007-003233-16-BE
(EUCTR)
05/09/200722/08/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. HIV-associated lipodystrophy
MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: Tesamorelin
Product Code: TH9507
INN or Proposed INN: Tesamorelin
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
5EUCTR2006-005444-88-DE
(EUCTR)
21/06/200714/08/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat AccumulationA Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation HIV-associated lipodystrophy
MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot RecruitingFemale: yes
Male: yes
400United Kingdom;Germany;France;Spain
6EUCTR2006-005444-88-GB
(EUCTR)
08/05/200726/01/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat AccumulationA Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation HIV-associated lipodystrophy
MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Germany;United Kingdom
7EUCTR2006-005444-88-ES
(EUCTR)
25/04/200703/03/2010A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal.A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal. HIV-associated lipodystrophyLipodistrofia asociada al VIH
MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot RecruitingFemale: yes
Male: yes
400Germany;United Kingdom;France;Spain
8EUCTR2006-005444-88-FR
(EUCTR)
15/02/200711/01/2007A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat AccumulationA Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation HIV-associated lipodystrophy
MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Germany;United Kingdom;France;Spain
9EUCTR2006-005444-88-BE
(EUCTR)
16/01/200721/12/2006A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat AccumulationA Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation HIV-associated lipodystrophy
MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Theratechnologies Inc.NULLNot RecruitingFemale: yes
Male: yes
400France;Spain;Belgium;Germany;United Kingdom
10NCT00130286
(ClinicalTrials.gov)
March 200512/8/2005Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin ResistanceRandomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin ResistanceHIV-Associated Lipodystrophy Syndrome;Insulin Resistance;HIV Infections;Metabolic Syndrome X;Body Weight ChangesDrug: Rosiglitazone;Drug: Recombinant human growth hormone + rosiglitazoneWeill Medical College of Cornell UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years65 YearsAll77Phase 1/Phase 2United States
11NCT00119769
(ClinicalTrials.gov)
February 20057/7/2005The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected PatientsThe Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)HIV Infections;LipodystrophyDrug: Placebo;Drug: Genotropin (human recombinant Growth hormone)Hvidovre University HospitalPfizerCompleted21 Years60 YearsMale46Phase 4Denmark
12NCT00100698
(ClinicalTrials.gov)
January 20044/1/2005Physiologic Growth Hormone Effects in HIV LipodystrophyPhysiologic Growth Hormone Effects in HIV LipodystrophyAIDS;HIV InfectionsDrug: recombinant human growth hormone;Drug: placeboMassachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll56N/AUnited States