78. Hypopituitarism Clinical trials / Disease details


Clinical trials : 492 Drugs : 341 - (DrugBank : 47) / Drug target genes : 45 - Drug target pathways : 100

  
255 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04867317
(ClinicalTrials.gov)
May 1, 20238/4/2021Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone Deficiency;Mild Traumatic Brain InjuryDrug: Somatropin;Other: PlaceboVA Office of Research and DevelopmentNULLNot yet recruiting21 Years55 YearsAll172Phase 3United States
2EUCTR2020-000929-42-NL
(EUCTR)
14/04/202223/02/2021Trial 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)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
Product Code: H01AC01
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;Turkey;Israel;United Kingdom;Italy;France;Armenia;Canada;Poland;Romania;Denmark;Australia;Georgia;Bulgaria;Netherlands;Germany;Japan;New Zealand
3EUCTR2020-000929-42-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
4JPRN-jRCT2031210366
16/11/202105/10/2021An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiencyAn extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency Growth hormone deficiency in children[Investigational product]
JR-142
0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection
[Comparatar product]
INN: Somatropin
0.175 mg/kg/week, daily subcutaneous injection
Ibaraki RyoNULLNot RecruitingNot applicableNot applicableBoth24Phase 2Japan
5EUCTR2020-000929-42-IT
(EUCTR)
18/10/202108/06/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: Norditropin FlexPro 5mg/1.5 ml
Product Code: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden
6EUCTR2020-000929-42-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 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
7EUCTR2020-000929-42-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 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
8JPRN-jRCT2051200129
02/06/202102/02/2021A trial to compare once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyA multicenter, randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)-Drug: Lonapegsomatropin
Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
-Other: Placebo
The placebo for lonapegsonatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin.
-Drug: Somatropin
Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
Beckert MichaelNULLRecruiting>= 23age old<= 80age oldBoth240Phase 3Australia;Belarus;Bulgaria;Canada;Denmark;France;Georgia;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Poland;Romania;Russia;Serbia;Slovakia;Spain;Turkey;UK;Ukraine;USA;Armenia;Japan
9JPRN-jRCT2031200372
21/05/202119/02/2021Phase 2 study of JR-142 in pediatric patients with growth hormone deficiencyPhase 2 study of JR-142 in pediatric patients with growth hormone deficiency Growth hormone deficiency in children[Investigational product]
JR-142
0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection
[Comparatar product]
INN: Somatropin
0.175 mg/kg/week, daily subcutaneous injection
Ryo IbarakiNULLNot Recruiting>= 3age old< 10age oldBoth24Phase 2Japan
10EUCTR2020-000929-42-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
11EUCTR2020-000929-42-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
12EUCTR2020-000929-42-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
13NCT04615273
(ClinicalTrials.gov)
December 3, 202029/10/2020A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyforesiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyGrowth Hormone Deficiency;Endocrine System Diseases;Hormone DeficiencyDrug: Lonapegsomatropin;Other: Placebo;Drug: SomatropinAscendis Pharma Endocrinology Division A/SNULLRecruiting23 Years80 YearsAll240Phase 3United States;Armenia;Australia;Canada;Georgia;Greece;Japan;New Zealand;Poland;Slovakia;Turkey;Ukraine
14EUCTR2018-000231-27-ES
(EUCTR)
21/04/202028/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
15EUCTR2018-000231-27-PL
(EUCTR)
23/03/202004/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Germany;Norway;Japan;United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland
16EUCTR2018-000231-27-HU
(EUCTR)
23/03/202005/02/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of
17EUCTR2018-000231-27-LV
(EUCTR)
05/03/202015/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Germany;Latvia;Norway;Algeria;Japan;Korea, Republic of
18EUCTR2018-000231-27-EE
(EUCTR)
17/02/202014/01/2020A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3Serbia;United States;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
19NCT04020913
(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
20EUCTR2018-000231-27-SI
(EUCTR)
17/07/201914/06/2019A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Japan
21EUCTR2018-000918-38-BG
(EUCTR)
16/07/201923/05/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
22EUCTR2018-000918-38-SK
(EUCTR)
11/07/201911/02/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
23EUCTR2018-000918-38-CZ
(EUCTR)
27/06/201920/03/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
24EUCTR2018-000231-27-GB
(EUCTR)
30/05/201903/09/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Russian Federation;United States;Thailand;Austria;Latvia;Ireland;Korea, Republic of;Poland;Algeria;Slovenia;France;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;Canada;European Union;Norway;Denmark;Italy;Israel;Germany;Estonia
25EUCTR2018-000231-27-AT
(EUCTR)
22/05/201902/04/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
26EUCTR2018-000918-38-GB
(EUCTR)
16/05/201927/11/2018STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
27EUCTR2018-000231-27-DK
(EUCTR)
15/05/201928/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Algeria;Japan
28EUCTR2018-000231-27-DE
(EUCTR)
23/04/201911/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan
29EUCTR2018-000231-27-IT
(EUCTR)
19/04/201930/07/2021A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290S
Product Code: [NN8640]
INN or Proposed INN: Somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Product Name: Norditropin FlexPro 10 mg/1.5 ml
Product Code: [N/A]
INN or Proposed INN: somatropin
Other descriptive name: somatropin
NOVO NORDISK. S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan
30NCT04513171
(ClinicalTrials.gov)
December 26, 20187/8/2020Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency ChildrenA Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.Growth Hormone DeficiencyDrug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: NorditropinXiamen Amoytop Biotech Co., Ltd.Tongji HospitalActive, not recruiting3 Years11 YearsAll434Phase 2/Phase 3China
31ChiCTR1800017144
2018-07-252018-07-13A diverse response study of Pegylated Somatropin to treat growth hormone deficiency childrenA diverse response study of Pegylated Somatropin to treat growth hormone deficiency children Growth hormone deficiencyTwo groups:low dose versus high dose of Pegylated Somatropin;The Children's Hospital, Zhejiang University School of MedicineNULLRecruiting314BothTwo groups:900;China‘
32EUCTR2016-004580-39-IT
(EUCTR)
18/07/201801/06/2021Treatment of Growth Hormone Deficiency in patient with Chronic Heart FailureTreatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study - Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-B Growth Hormone Deficiency associated with Chronic Heart Failure
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]
Trade Name: SAIZEN - 1 FLACONCINO POLV. 8 MG + 1 CARTUCCIA. SOLV. INSERITI IN UN DISPOSITIVO PER LA RICOSTITUZIONE
Product Name: somatropina
Product Code: [026863100]
INN or Proposed INN: SOMATROPINA
Other descriptive name: somatropin
AOU FEDERICO IINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3Italy
33EUCTR2016-001145-11-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
34JPRN-JapicCTI-183963
25/12/201717/05/2018Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY Treatment of children with growth failure due to growth hormone deficiency (GHD)Intervention name : Somatrogon (Genetical Recombination)
INN of the intervention : somatrogon
Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Control intervention name : Genotropin
INN of the control intervention : somatropin
Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day).
OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd)NULLcomplete311BOTH44Phase 3Japan
35EUCTR2016-003874-42-GR
(EUCTR)
20/12/201721/11/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand
36EUCTR2016-003874-42-GB
(EUCTR)
04/09/201703/01/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noTaiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus
37EUCTR2016-003874-42-DE
(EUCTR)
04/08/201701/02/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand
38EUCTR2016-003874-42-IT
(EUCTR)
16/06/201706/09/2021An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
PRM|21097NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy
39EUCTR2016-003874-42-ES
(EUCTR)
18/05/201714/03/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand
40EUCTR2016-003874-42-BG
(EUCTR)
26/04/201713/02/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand
41EUCTR2016-001145-11-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
42NCT03104010
(ClinicalTrials.gov)
April 201728/3/2017A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHDA Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: Somatropin InjectionGeneScience Pharmaceuticals Co., Ltd.Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China HospitalRecruiting18 Years60 YearsAll180Phase 2China
43EUCTR2016-001145-11-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
44EUCTR2016-001145-11-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
45NCT03290235
(ClinicalTrials.gov)
March 1, 201719/9/2017Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenThe Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenGrowth RetardationDrug: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting42 Months15 YearsAll1500Phase 4China
46NCT02968004
(ClinicalTrials.gov)
December 201613/11/2016Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenA Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOPKO Health, Inc.NULLActive, not recruiting3 Years11 YearsAll224Phase 3United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey
47EUCTR2015-001939-21-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
48NCT03015909
(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
49EUCTR2015-001939-21-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
50EUCTR2015-001939-21-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
51EUCTR2015-001939-21-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
52EUCTR2015-000531-32-DE
(EUCTR)
14/03/201620/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
53EUCTR2015-000531-32-BE
(EUCTR)
17/02/201630/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden
54EUCTR2015-000531-32-SE
(EUCTR)
14/01/201604/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
55EUCTR2014-002736-13-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
56EUCTR2015-000531-32-SI
(EUCTR)
15/12/201511/11/2015A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
57EUCTR2015-000531-32-AT
(EUCTR)
10/12/201503/11/2015A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormoneA randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
58EUCTR2014-002736-13-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
59EUCTR2015-001939-21-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
60EUCTR2015-001939-21-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
61EUCTR2014-002736-13-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
62EUCTR2015-001939-21-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
63EUCTR2005-000384-26-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
64EUCTR2013-002892-16-LV
(EUCTR)
12/10/201531/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden
65EUCTR2014-002736-13-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
66EUCTR2013-002892-16-LT
(EUCTR)
30/09/201527/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
67EUCTR2014-002736-13-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
68EUCTR2014-002736-13-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
69EUCTR2014-002736-13-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
70EUCTR2014-002736-13-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
71EUCTR2015-001939-21-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
72EUCTR2014-002698-13-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
73EUCTR2014-002736-13-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
74EUCTR2014-002736-13-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
75EUCTR2014-002736-13-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
76EUCTR2014-002698-13-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
77EUCTR2013-004468-69-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
78EUCTR2014-002736-13-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
79EUCTR2014-002736-13-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
80NCT02311894
(ClinicalTrials.gov)
March 31, 20154/12/2014A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone DeficiencyA Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)Growth Hormone DeficiencyDrug: SomatropinGenentech, Inc.NULLCompleted3 Years14 YearsAll82Phase 4United States
81EUCTR2014-002698-13-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
82EUCTR2013-004468-69-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
83EUCTR2014-002698-13-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
84NCT02382939
(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
85EUCTR2014-002698-13-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
86EUCTR2014-000290-39-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
87EUCTR2013-004468-69-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
88EUCTR2014-000290-39-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
90European Union;Denmark;United Kingdom;Japan;Sweden
89EUCTR2014-002698-13-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
90NCT02976675
(ClinicalTrials.gov)
January 201524/11/2016Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong UniversityRecruiting3 Years18 YearsAll600Phase 4China
91NCT03249480
(ClinicalTrials.gov)
January 201524/7/2017Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's HospitalRecruiting3 Years18 YearsAll900Phase 4China
92EUCTR2013-002892-16-DE
(EUCTR)
22/12/201429/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
93NCT02380235
(ClinicalTrials.gov)
December 20142/3/2015Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)Growth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 Years18 YearsAll600Phase 4China
94EUCTR2013-002892-16-GB
(EUCTR)
20/11/201424/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
95EUCTR2014-000290-39-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
96NCT02908958
(ClinicalTrials.gov)
November 201419/9/2016Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone DeficiencyClinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial IIGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second HospitalRecruiting3 Years18 YearsAll900Phase 4China
97NCT02314676
(ClinicalTrials.gov)
November 201427/11/2014Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenDwarfism, PituitaryBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 YearsN/ABoth900Phase 4China
98NCT02229851
(ClinicalTrials.gov)
October 31, 201426/8/2014Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension PeriodGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted23 Years79 YearsAll301Phase 3United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom
99EUCTR2013-002892-16-SE
(EUCTR)
07/10/201403/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
100EUCTR2013-004468-69-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
101EUCTR2013-004468-69-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
102NCT02018172
(ClinicalTrials.gov)
July 201417/12/2013Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X DeviceGrowth Hormone Deficiency;Turner's SyndromeDrug: somatropinFerring PharmaceuticalsNULLTerminatedN/AN/ABoth3N/AFrance
103EUCTR2013-004468-69-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
104NCT02092077
(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
105EUCTR2011-001826-61-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
106EUCTR2013-000013-20-ES
(EUCTR)
02/01/201410/01/2014A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Phase 1France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden
107EUCTR2013-000013-20-SE
(EUCTR)
20/12/201312/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
108EUCTR2013-000013-20-BE
(EUCTR)
17/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
109EUCTR2013-000013-20-AT
(EUCTR)
16/12/201311/12/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
110NCT01973244
(ClinicalTrials.gov)
December 16, 201322/10/2013A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone DeficiencyA Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years13 YearsAll32Phase 1Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland
111EUCTR2013-000013-20-SI
(EUCTR)
09/12/201320/09/2013A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
112EUCTR2012-002787-27-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
113EUCTR2012-004975-37-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
114EUCTR2012-004975-37-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
115EUCTR2012-002787-27-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
116EUCTR2012-004975-37-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
117EUCTR2012-002787-27-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
118EUCTR2012-004975-37-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
119EUCTR2012-004263-47-CZ
(EUCTR)
13/05/201305/03/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
120EUCTR2012-002787-27-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
121EUCTR2012-004263-47-DE
(EUCTR)
03/04/201325/02/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
122EUCTR2011-004553-60-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
123EUCTR2012-004975-37-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
124EUCTR2012-002787-27-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
125NCT01494779
(ClinicalTrials.gov)
March 201328/11/2011Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.GH Deficiency (GHD);Growth RetardationDrug: SomatropinL.A.L Clinica Pesquisa e Desenvolvimento Ltda.NULLNot yet recruiting18 Years32 YearsMale32Phase 1Brazil
126EUCTR2012-004975-37-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
127EUCTR2012-002787-27-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
128EUCTR2012-004975-37-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
129NCT01731028
(ClinicalTrials.gov)
January 201316/11/2012Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical PracticeGrowth Hormone DeficiencyDrug: SomatropinFerring PharmaceuticalsNULLWithdrawn3 Years18 YearsBoth0N/ANULL
130EUCTR2011-005377-23-ES
(EUCTR)
18/07/201221/05/2012Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). Spinal Cord Injury and Growth Hormone Deficiency
MedDRA version: 14.1;Level: PT;Classification code 10041558;Term: Spinal cord injury thoracic;System Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1;Classification code 10041554;Term: Spinal cord injury cervical;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Trade Name: NUTROPIN
Product Name: NutropinAq 10 mg/2 ml (30 UI)
INN or Proposed INN: SOMATROPIN
Guillem Cuatrecasas CambraNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
131EUCTR2011-004553-60-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
132EUCTR2011-004553-60-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
133NCT01592500
(ClinicalTrials.gov)
February 20122/5/2012Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenSafety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOPKO Health, Inc.NULLCompleted3 Years11 YearsAll56Phase 2Greece;Hungary;Slovakia
134EUCTR2011-001826-61-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
135EUCTR2011-004553-60-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
136EUCTR2011-004553-60-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
137EUCTR2011-004553-60-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
138NCT01440686
(ClinicalTrials.gov)
September 201123/9/2011Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male VolunteersA Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male VolunteersGrowth Hormone DeficiencyDrug: Somatropin;Drug: PlaceboHanAll BioPharma Co., Ltd.NULLCompleted19 Years50 YearsMale40Phase 1Korea, Republic of
139EUCTR2011-000460-10-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
140EUCTR2011-000460-10-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
141EUCTR2011-000460-10-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
142EUCTR2011-001826-61-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
143EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
144EUCTR2010-020742-10-ES
(EUCTR)
01/04/201107/01/2011Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplicaTratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Finland;United Kingdom;Spain;Sweden
145EUCTR2010-023430-23-GB
(EUCTR)
28/03/201124/01/2011A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;Czech Republic;United Kingdom
146EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
147EUCTR2010-019374-32-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
148EUCTR2010-023430-23-CZ
(EUCTR)
09/02/201125/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
149EUCTR2010-023430-23-HU
(EUCTR)
17/01/201110/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
150EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
151EUCTR2009-017354-12-GB
(EUCTR)
08/11/201018/06/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden
152NCT01243892
(ClinicalTrials.gov)
November 201017/11/2010A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin DeviceA Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®Growth Hormone DeficiencyDevice: NuSpin;Drug: SomatropinGenentech, Inc.NULLTerminated2 Years14 YearsAll18Phase 4United States
153EUCTR2009-017354-12-SE
(EUCTR)
11/10/201009/04/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Czech Republic;Sweden
154EUCTR2010-021523-28-DE
(EUCTR)
05/10/201010/08/2010A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
155EUCTR2010-021523-28-IT
(EUCTR)
28/09/201027/12/2010A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - NDA phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND Growth Hormone Deficiency
MedDRA version: 9.1;Level: PT;Classification code 10056438
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: OMNITROPE
INN or Proposed INN: Somatropin
ASCENDIS PHARMA A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Germany;Denmark;Italy;Austria;Sweden
156EUCTR2010-021523-28-SE
(EUCTR)
27/09/201006/08/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
157EUCTR2010-019374-32-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
158EUCTR2010-021523-28-DK
(EUCTR)
13/09/201029/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Austria;Denmark;Germany;Italy;Sweden
159EUCTR2010-019374-32-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
160EUCTR2010-019374-32-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
161EUCTR2010-021523-28-AT
(EUCTR)
02/09/201020/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
162EUCTR2009-017354-12-DE
(EUCTR)
29/07/201008/06/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Czech Republic;Germany;Sweden
163EUCTR2010-019374-32-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
164EUCTR2009-017354-12-CZ
(EUCTR)
22/06/201014/04/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Czech Republic;Sweden
165EUCTR2009-017354-12-SK
(EUCTR)
09/06/201026/05/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Trade Name: Genotropin 5.3 mg in injection system Genotropin pen
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Trade Name: Genotropin 12 mg
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Czech Republic;Slovakia;Germany;United Kingdom;Sweden
166NCT01613573
(ClinicalTrials.gov)
March 20101/6/2012Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenA Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenGrowth Hormone DeficiencyDrug: somatropin AQ;Drug: pegylated somatropinGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and TechnologyCompleted4 Years10 YearsMale12Phase 1NULL
167EUCTR2008-008240-25-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
168EUCTR2008-008240-25-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
169EUCTR2008-008240-25-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
170NCT01109017
(ClinicalTrials.gov)
October 200919/4/2010Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone DeficiencyA Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHDGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth387N/AJapan
171EUCTR2008-008240-25-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
172EUCTR2009-010918-30-IE
(EUCTR)
11/08/200911/03/2009Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care.
MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism
MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism
MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency
MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma
MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma
MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease
MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour
MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign
Trade Name: Genotropin 5.3mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin 12mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.4mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.6mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.8mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.0mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniqu
Amar Agha, Beaumont HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Ireland
173NCT00936403
(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
174EUCTR2008-004849-28-HU
(EUCTR)
09/07/200903/06/2009A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency - Idiopathic growth hormone deficiency.
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Zomacton 10 mg/ml
INN or Proposed INN: Somatropin
Trade Name: Genotropin 12 mg/ml
INN or Proposed INN: Somatropin
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
138Hungary
175NCT00934063
(ClinicalTrials.gov)
July 20092/7/2009An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)Growth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Other: No treatment givenNovo Nordisk A/SNULLCompleted18 YearsN/ABoth121N/AGermany
176EUCTR2008-008240-25-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
177EUCTR2008-008240-25-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
178NCT00837863
(ClinicalTrials.gov)
March 20092/2/2009Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone DeficiencyA Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomatropinAltus PharmaceuticalsNULLRecruiting3 Years13 YearsBoth36Phase 2United States
179NCT00630487
(ClinicalTrials.gov)
May 200828/2/2008Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone DeficiencyProspective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)Growth Hormone DeficiencyDrug: Placebo;Drug: SomatropinPfizerNULLTerminated18 Years65 YearsAll9Phase 3Germany
180EUCTR2007-000790-36-DE
(EUCTR)
08/01/200812/12/2007Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD StudyProspective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study Isolated Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin 5 mg/ml
INN or Proposed INN: Somatropin
Trade Name: Genotropin 5 mg/ml
INN or Proposed INN: Somatropin
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
50Germany
181EUCTR2007-003586-41-ES
(EUCTR)
26/11/200720/11/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A Tratamiento del déficit de hormona de crecimiento en adultos después de un traumatismo cerebral.
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (Marca internacional Genotropin)
Product Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para sol. inyectable (Marca internacional Genotropin)
INN or Proposed INN: Somatropina
Pfizer, S.ANULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;Spain;Netherlands;Italy;United Kingdom;Sweden
182NCT01306357
(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
183EUCTR2006-002278-24-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
184EUCTR2006-002278-24-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
185EUCTR2006-002278-24-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
186EUCTR2006-002278-24-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
187NCT00432263
(ClinicalTrials.gov)
April 20075/2/2007Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain InjuryBrain InjuriesDrug: Genotropin (PN-180,307) SomatropinPfizerNULLWithdrawn18 Years55 YearsBoth0Phase 4NULL
188NCT00455260
(ClinicalTrials.gov)
April 20072/4/2007A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-DeficiencyA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ SystemTeva Neuroscience, Inc.Teva Pharmaceutical Industries;TransPharma MedicalCompleted20 Years60 YearsBoth60Phase 1Israel;Ukraine
189NCT00601419
(ClinicalTrials.gov)
March 200715/1/2008Drug Use Investigation of Somatropin for GHD-ADULTS.Drug Use Investigation of GENOTROPIN for GHD-ADULTS.Dwarfism, Growth Hormone DeficiencyDrug: SomatropinPfizerNULLCompletedN/AN/AAll230N/ANULL
190NCT01495468
(ClinicalTrials.gov)
March 200716/12/2011Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenPegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical TrialGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin UniversityCompleted8 Years15 YearsAll343Phase 3China
191EUCTR2006-002278-24-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
192EUCTR2005-000346-36-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
193EUCTR2006-002278-24-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
194EUCTR2006-002278-24-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
195EUCTR2006-002278-24-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
196NCT01342146
(ClinicalTrials.gov)
May 200621/4/2011Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency ChildrenEfficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 StudyGrowth Hormone DeficiencyDrug: pegylated Somatropin;Drug: Jintropin AQGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan UniversityCompletedN/AN/AAll101Phase 2NULL
197NCT00960128
(ClinicalTrials.gov)
April 1, 200613/8/2009Observational Prospective Study on Patients Treated With Norditropin®NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll21249N/AArgentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro
198EUCTR2005-000384-26-IT
(EUCTR)
23/03/200602/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiencyA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency Growth hormone deficiency in adult
MedDRA version: 6.1;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: Somatropin
BIOPARTNERS GMBHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden
199EUCTR2005-004478-26-SE
(EUCTR)
13/01/200628/10/2005Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines.Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours.Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
INN or Proposed INN: somatropin
Karolinska universitetssjukhusetNULLNot RecruitingFemale: yes
Male: yes
Sweden
200EUCTR2005-000384-26-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
201EUCTR2005-000384-26-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
202EUCTR2005-000384-26-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
203EUCTR2005-000384-26-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
204EUCTR2005-000384-26-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
205EUCTR2005-000346-36-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
206EUCTR2005-000384-26-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
207NCT00271518
(ClinicalTrials.gov)
September 200529/12/2005Treatment of Children With Insufficient Secretion of Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth HormoneGrowth Hormone Deficiency (GHD)Drug: growth hormone (somatropin)LG Life SciencesBioPartners GmbHActive, not recruiting3 Years11 YearsBoth144Phase 3United States
208EUCTR2005-000384-26-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
209EUCTR2005-000346-36-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
210EUCTR2005-000346-36-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
211NCT01604161
(ClinicalTrials.gov)
May 200521/5/2012Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner SyndromeA Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth2016N/AJapan
212EUCTR2004-000356-17-DK
(EUCTR)
19/04/200529/11/2004PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy
213EUCTR2004-000356-17-AT
(EUCTR)
12/03/200502/05/2005Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - OptimaPhase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq(tm) is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Austria;Italy
214EUCTR2004-004835-72-GB
(EUCTR)
12/01/200517/02/2005A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) Growth hormone deficiency in adult lifeTrade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx 5mg/1.5ml
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone, GH
University of BirminghamUniversity Hospital Birmingham Foundation NHS TrustNot RecruitingFemale: yes
Male: yes
200United Kingdom
215NCT00163189
(ClinicalTrials.gov)
January 20059/9/2005Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By GenotonormEvolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By GenotonormGrowth Hormone DeficiencyDrug: SomatropinPfizerNULLCompletedN/AN/AAll98Phase 3France
216NCT00184730
(ClinicalTrials.gov)
November 200413/9/2005Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.Growth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted19 Years67 YearsBoth86Phase 3Japan
217NCT00080483
(ClinicalTrials.gov)
March 20045/4/2004Testosterone and Growth Hormone for Bone Loss in MenWill Testosterone and Growth Hormone Improve Bone Structure?Hypopituitarism;Hypogonadism;Growth Hormone DeficiencyDrug: Testosterone plus somatropin;Drug: testosteroneUniversity of PennsylvaniaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 YearsN/AMale35Phase 2United States
218NCT00191165
(ClinicalTrials.gov)
March 200412/9/2005Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone DeficiencyEfficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyNULLCompletedN/A14 YearsAll27Phase 3Italy
219NCT00184743
(ClinicalTrials.gov)
December 6, 200313/9/2005Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years65 YearsAll112Phase 3Japan
220NCT02693522
(ClinicalTrials.gov)
October 200319/1/2016Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone DeficiencyPhase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: somatropin;Drug: EutropinDaewoong Pharmaceutical Co. LTD.NULLCompleted18 YearsN/ABoth52Phase 3Korea, Republic of
221NCT01580605
(ClinicalTrials.gov)
July 17, 200313/4/2012French National Registry of Adults With Growth Hormone Deficiency Treated With SomatropinProspective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was StartedGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll331France
222NCT01543880
(ClinicalTrials.gov)
July 200328/2/2012Safety and Efficacy of Long-term Somatropin Treatment in AdultsNon-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in AdultsGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted20 YearsN/ABoth752N/AGermany
223NCT00600808
(ClinicalTrials.gov)
June 200323/7/2007Sustained Release Formulation of Somatropin (rDNA Origin)for InjectionA Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.Growth Hormone DeficiencyDrug: BPLG-003BioPartners GmbHLG Life SciencesCompleted4 Years10 YearsBoth51Phase 2/Phase 3NULL
224NCT00476385
(ClinicalTrials.gov)
June 200321/5/2007Practicability and Acceptability of Stylomax® in ChildrenUsability and Acceptability of Stylomax® in Growth Hormone Deficient Children.Growth Hormone DeficiencyDrug: somatropineSanofiNULLCompleted3 Years18 YearsBoth12Phase 3France
225NCT00519558
(ClinicalTrials.gov)
May 31, 200320/8/2007Growth Hormone Deficiency in Adults (GHDA)Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years65 YearsAll121Phase 3Japan
226NCT00567385
(ClinicalTrials.gov)
March 10, 200330/11/2007Liquid Somatropin Formulation in Children With Growth Hormone DeficiencyAn Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years18 YearsAll176Phase 4Turkey
227NCT00191360
(ClinicalTrials.gov)
January 200312/9/2005Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone DeficiencyExtended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyNULLCompleted18 Years65 YearsBoth68Phase 3Japan
228NCT00638053
(ClinicalTrials.gov)
November 200211/3/2008A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head InjuryHead Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head InjuryBrain Injuries;Growth Hormone Deficiency DwarfismGenetic: somatropinPfizerNULLTerminated18 YearsN/ABoth100Phase 4United States
229NCT01088399
(ClinicalTrials.gov)
September 200225/2/2010A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient AdultsThe Global Hypopituitary Control and Complications StudyHypopituitarism;Pituitary Insufficiency;Growth Hormone Deficiency, AdultDrug: Somatropin (rDNA origin)Eli Lilly and CompanyNULLCompleted18 YearsN/AAll10673N/ANULL
230NCT01009905
(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
231NCT00184678
(ClinicalTrials.gov)
February 200213/9/2005Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone DeficiencyEffect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years25 YearsAll161Phase 3Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom
232NCT00136032
(ClinicalTrials.gov)
January 200224/8/2005Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient WomenGender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Somatropin;Drug: PlaceboMassachusetts General HospitalNULLCompleted18 Years65 YearsFemale63N/AUnited States
233NCT01698944
(ClinicalTrials.gov)
May 16, 20011/10/2012Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone DeficiencyCardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNULLTerminated12 Years25 YearsAll7Phase 4Greece
234NCT01502124
(ClinicalTrials.gov)
May 8, 200129/12/2011Safety and Efficacy of Somatropin in Children With Growth Hormone DeficiencyNorditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years17 YearsAll78Phase 3United States
235NCT01543867
(ClinicalTrials.gov)
January 200128/2/2012Safety and Efficacy of Long-term Somatropin Treatment in ChildrenNon-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)Growth Hormone Disorder;Growth Hormone Deficiency in Children;Foetal Growth Problem;Small for Gestational Age;Genetic Disorder;Turner Syndrome;Growth Disorder;Idiopathic Short StatureDrug: somatropinNovo Nordisk A/SNULLCompletedN/A18 YearsBoth5442N/AGermany
236NCT01563926
(ClinicalTrials.gov)
October 23, 200023/3/2012Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone DeficiencyAn Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll168Phase 3Israel
237NCT00262249
(ClinicalTrials.gov)
August 20005/12/2005Effect of Growth Hormone in Children With Growth Hormone DeficiencyEffect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short StatureGrowth Hormone Disorder;Growth Hormone Deficiency in Children;Growth Disorder;Idiopathic Short StatureDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years15 YearsAll173Phase 3United States
238NCT00931476
(ClinicalTrials.gov)
April 6, 200030/6/2009A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of SomatropinA Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)Growth Hormone Disorder;Adult Growth Hormone Deficiency;HealthyDrug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted20 Years50 YearsMale86Phase 1United States
239NCT00490191
(ClinicalTrials.gov)
January 199920/6/2007Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone DeficiencyComparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone DeficiencyHypopituitarismDrug: SomatropinEli Lilly and CompanyNULLCompleted20 YearsN/ABoth387Phase 4United States;France;Germany;Italy;Puerto Rico;United Kingdom
240NCT01562834
(ClinicalTrials.gov)
October 21, 199822/3/2012Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult PatientsRandomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult PatientsGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years50 YearsAll22Phase 4France
241NCT00570011
(ClinicalTrials.gov)
June 19977/12/2007Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult PatientsEfficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult PatientsGrowth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyUniversity of Naples;University of Padua;University of Milan;University of PisaCompleted18 YearsN/ABoth112Phase 3United States
242NCT00174278
(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
243EUCTR2018-000231-27-IE
(EUCTR)
26/11/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNA Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Norway;Algeria;Japan;Korea, Republic of
244EUCTR2018-000231-27-FR
(EUCTR)
25/02/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNA Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Norway;Germany;Algeria;Japan;Korea, Republic of
245EUCTR2009-017354-12-NL
(EUCTR)
30/07/2010A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PENA MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
Product Name: Genotropin Mark VII pen
Product Code: PN-180307
INN or Proposed INN: Somatropin
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
INN or Proposed INN: SOMATROPIN
Other descriptive name: n/a
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNAFemale: yes
Male: yes
130Phase 3Czech Republic;Slovakia;Germany;Netherlands;United Kingdom;Sweden
246EUCTR2013-004468-69-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
247EUCTR2016-001145-11-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
248EUCTR2016-003874-42-FR
(EUCTR)
06/03/2017 An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLNA Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand
249EUCTR2013-000013-20-FR
(EUCTR)
25/09/2015A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiencyA randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency Growth hormone deficiency in children
MedDRA version: 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 DP 6.7 mg ml 3 ml cartridge
INN or Proposed INN: n/a
Other descriptive name: NNC0195-0092
Trade Name: Norditropin SimpleXx 10 mg
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
32Phase 1France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
250EUCTR2012-002787-27-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
251EUCTR2018-000231-27-NO
(EUCTR)
14/11/2019A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
192Phase 3Russian Federation;United States;Thailand;Austria;Latvia;Ireland;Korea, Republic of;Poland;Algeria;Slovenia;Serbia;France;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;Canada;Norway;European Union;Denmark;Italy;Israel;Germany;Estonia
252EUCTR2016-003874-42-PL
(EUCTR)
14/03/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLNAFemale: yes
Male: yes
220Phase 3United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand
253EUCTR2016-000446-56-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
254EUCTR2017-000914-47-Outside-EU/EEA
(EUCTR)
23/05/2017Growth hormone treatment in children born small for gestational age (SGA)A long-term, multi-centre, randomised, controlled, double-blind, parallel-group trial, investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational ageExtension to trial GHLiquid-1516: A 104-week, multi-centre, randomised, double-blind, parallel-group, no treatment controlled (open-label) trial investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age Foetal growth problemSmall for Gestational AgeGrowth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: NN-220
INN or Proposed INN: SOMATROPIN
Other descriptive name: SOMATROPIN
Product Name: NN-220
INN or Proposed INN: SOMATROPIN
Other descriptive name: SOMATROPIN
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
86Phase 3Japan
255EUCTR2010-019374-32-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