Genotropin ( DrugBank: - )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
78下垂体前葉機能低下症121
107若年性特発性関節炎3
187歌舞伎症候群1
193プラダー・ウィリ症候群4

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-006465-16-DE
(EUCTR)
03/05/2007Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MSPilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: human recombinant growth hormone
University of LeipzigNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany

78. 下垂体前葉機能低下症


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031200340
14/06/202102/02/2021A trial to compare lonapegsomatropin (TransCon hGH) administered once a week and standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency (GHD)A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the efficacy, safety, and tolerability of lonapegsomatropin (TransCon hGH) administered once a week versus standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency(GHD) - riGHt Pediatric growth hormon deficiency

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

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

Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector.
Beckert MichaelNULLRecruiting>= 3age old<= 16age oldBoth50Phase 3Japan
2EUCTR2018-000918-38-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
3EUCTR2018-000918-38-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
4EUCTR2018-000918-38-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
5EUCTR2018-000918-38-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
6NCT03878992
(ClinicalTrials.gov)
April 30, 20197/3/2019Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleEffects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleGrowth Hormone Deficiency;Growth Hormone TreatmentDrug: Genotropin miniquick 0.5 mg, injectionUniversity of AarhusAarhus University HospitalRecruiting18 Years100 YearsAll12N/ADenmark
7NCT03831880
(ClinicalTrials.gov)
February 7, 201921/12/2018Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHDA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYGrowth Hormone DeficiencyDrug: Genotropin;Drug: somatrogonPfizerNULLCompleted3 Years17 YearsAll87Phase 3United States;Bulgaria;Czechia;Slovakia;United Kingdom
8EUCTR2016-001145-11-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
9JPRN-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
10EUCTR2016-003874-42-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
11NCT03874013
(ClinicalTrials.gov)
December 7, 20171/10/2018Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: MOD-4023;Drug: GenotropinOPKO Health, Inc.NULLCompleted3 Years11 YearsAll44Phase 3Japan
12EUCTR2016-003874-42-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
13EUCTR2016-003874-42-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
14EUCTR2016-003874-42-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
15EUCTR2016-003874-42-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
16EUCTR2016-003874-42-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
17EUCTR2016-001145-11-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
18EUCTR2016-001145-11-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
19EUCTR2016-001145-11-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
20NCT02781727
(ClinicalTrials.gov)
December 13, 201619/5/2016A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone Deficiency, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary DiseasesDrug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of GenotropinAscendis Pharma Endocrinology Division A/SNULLCompleted3 Years12 YearsAll161Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine
21NCT02968004
(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
22EUCTR2015-001939-21-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
23EUCTR2015-001939-21-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
24EUCTR2015-001939-21-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
25EUCTR2015-001939-21-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
26NCT03309891
(ClinicalTrials.gov)
January 18, 20165/9/2017Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone DeficiencyA Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.NULLCompleted3 Years11 YearsAll56Phase 2Ukraine
27EUCTR2014-002736-13-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
28EUCTR2014-002736-13-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
29EUCTR2015-001939-21-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
30EUCTR2015-001939-21-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
31EUCTR2014-002736-13-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
32EUCTR2015-001939-21-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
33EUCTR2014-002736-13-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
34EUCTR2014-002736-13-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
35EUCTR2014-002736-13-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
36EUCTR2014-002736-13-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
37EUCTR2014-002736-13-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
38EUCTR2015-001939-21-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
39EUCTR2014-002698-13-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
40EUCTR2014-002736-13-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
41EUCTR2014-002736-13-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
42EUCTR2014-002736-13-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
43EUCTR2014-002698-13-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
44EUCTR2013-004468-69-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
45EUCTR2014-002736-13-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
46EUCTR2014-002736-13-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
47NCT02410356
(ClinicalTrials.gov)
April 30, 201530/3/2015A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyA Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: dGHTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 YearsN/AAll34Phase 3United States;Austria;Czechia;Greece;Hungary;Italy;Slovakia;Spain;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey;Ukraine
48EUCTR2014-002698-13-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
49EUCTR2013-004468-69-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
50EUCTR2014-002698-13-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
51EUCTR2014-002698-13-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
52EUCTR2013-004468-69-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
53EUCTR2014-002698-13-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
54NCT02946606
(ClinicalTrials.gov)
January 201528/8/2015A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.NULLCompleted20 Years65 YearsAll45Phase 2Korea, Republic of
55EUCTR2013-004468-69-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
56EUCTR2013-004468-69-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
57EUCTR2013-004468-69-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
58EUCTR2011-001826-61-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
59EUCTR2012-002787-27-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
60EUCTR2012-004975-37-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
61EUCTR2012-004975-37-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
62EUCTR2012-002787-27-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
63EUCTR2012-004975-37-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
64EUCTR2012-002787-27-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
65EUCTR2012-004975-37-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
66EUCTR2012-005066-36-NL
(EUCTR)
15/05/201323/01/2013To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiencyEffect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Genotropin
Trade Name: Norditropin
Trade Name: Humatrope
Trade Name: Zomacton
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
67EUCTR2012-002787-27-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
68EUCTR2011-004553-60-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
69EUCTR2012-004975-37-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
70EUCTR2012-002787-27-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
71EUCTR2012-004975-37-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
72EUCTR2012-002787-27-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
73EUCTR2012-004975-37-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
74EUCTR2011-004553-60-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
75EUCTR2011-004553-60-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
76EUCTR2011-001826-61-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
77EUCTR2011-004553-60-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
78EUCTR2011-004553-60-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
79EUCTR2011-004553-60-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
80NCT01822340
(ClinicalTrials.gov)
October 201125/3/2013Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency PatientsA Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: HM10560A;Drug: GenotropinHanmi Pharmaceutical Company LimitedNULLCompleted23 Years60 YearsBoth72Phase 2Hungary;Romania
81EUCTR2011-001826-61-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
82EUCTR2009-017354-12-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
83EUCTR2009-017354-12-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
84EUCTR2010-019374-32-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
85EUCTR2010-019374-32-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
86EUCTR2009-017354-12-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
87EUCTR2010-019374-32-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
88EUCTR2009-017354-12-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
89EUCTR2009-017354-12-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
90EUCTR2009-016783-37-SE
(EUCTR)
07/01/201016/10/2009The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GHThe Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH Growth hormone deficiency in adultsProduct Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
INN or Proposed INN: recombinant human growth hormone
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
91NCT00884000
(ClinicalTrials.gov)
January 201017/4/2009A Study of Zomacton in Children With Growth Hormone DeficiencyA Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Genotropin;Drug: ZomactonFerring PharmaceuticalsNULLCompleted3 Years11 YearsBoth165Phase 3Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine
92EUCTR2009-010918-30-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
93EUCTR2008-004849-28-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
94EUCTR2007-003586-41-IT
(EUCTR)
04/03/200801/07/2008PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - NDPLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND Growth hormone deficiency (GHD)after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: GenotropinPFIZERNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
95NCT00555009
(ClinicalTrials.gov)
March 200824/10/2007Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain InjuryPlacebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.Brain Injuries;Growth Hormone DeficiencyDrug: Genotropin;Drug: PlaceboPfizerNULLTerminated18 Years55 YearsAll10Phase 4France;Italy;Netherlands;Spain;Sweden;United Kingdom
96NCT00646815
(ClinicalTrials.gov)
March 200819/2/2008Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyInsulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (genotropin)University of AarhusAarhus University HospitalCompleted18 Years60 YearsBoth24N/ADenmark
97EUCTR2007-003586-41-FR
(EUCTR)
13/02/200814/11/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin/GENOTONORM®
Product Name: Genotropin/GENOTONORM®
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
98EUCTR2007-000790-36-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
99EUCTR2007-003586-41-NL
(EUCTR)
17/12/200709/08/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
100EUCTR2007-003586-41-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
101EUCTR2007-003586-41-SE
(EUCTR)
21/11/200712/09/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
102EUCTR2007-003586-41-GB
(EUCTR)
15/11/200711/10/2007Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Genotropin
Product Name: Genotropin
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
103NCT00432263
(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
104NCT00601419
(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
105EUCTR2005-000346-36-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
106EUCTR2006-001574-24-NL
(EUCTR)
06/10/200615/06/2006Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteriesTrade Name: Genotropin
Product Name: genotropin
Product Code: RVG 15790 or RVG 25480
Radboud University Nijmegen Medical Centre, Department of EndocrinologyNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
107EUCTR2005-005613-38-IE
(EUCTR)
31/05/200606/01/2006Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk? Hypopituitarism refers to decreased secretion of pituitary hormones, which can result from diseases of the pituitary gland or from diseases of the hypothalamus, which cause diminished secretion of hypothalamic releasing hormones, thereby reducing secretion of the corresponding pituitary hormones.Trade Name: Trisequens
Trade Name: Testogel
Trade Name: Genotropin MiniQuick
Dr. Chris ThompsonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Ireland
108NCT00517062
(ClinicalTrials.gov)
January 200615/8/2007Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production RatesEffects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient AdultsGrowth Hormone DeficiencyDrug: Growth hormone (Genotropin);Drug: PlaceboOregon Health and Science UniversityNULLCompleted18 Years75 YearsBoth16Phase 0United States
109EUCTR2005-000346-36-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
110EUCTR2005-000346-36-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
111EUCTR2005-000346-36-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
112NCT00929799
(ClinicalTrials.gov)
November 200329/6/2009Growth Hormone and Glucose MetabolismEffects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: recombinant human Growth Hormone (Genotropin® )Charite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth6Phase 4Germany
113NCT00638053
(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
114NCT00462475
(ClinicalTrials.gov)
January 199618/4/2007Effect of 5 Years of GH Replacement on AtherosclerosisPhase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary PatientsHypopituitarism;Pituitary Tumors;Growth Hormone DeficiencyDrug: Recombinant Growth Hormone, Genotropin (Pfizer)Federico II UniversityNULLCompleted18 Years50 YearsMale20Phase 4Italy
115EUCTR2013-004468-69-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
116EUCTR2016-003874-42-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
117EUCTR2009-017354-12-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
118EUCTR2016-003874-42-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
119EUCTR2012-002787-27-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
120EUCTR2016-001145-11-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
121EUCTR2016-000446-56-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

107. 若年性特発性関節炎


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00420251
(ClinicalTrials.gov)
March 19969/1/2007Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic ArthritisRecombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone DevelopmentJuvenile Idiopathic Arthritis;Still Disease, Juvenile-OnsetDrug: GenotropinLudwig-Maximilians - University of MunichPfizerCompleted4 Years14 YearsBoth50Phase 3Germany
2EUCTR2014-004104-30-Outside-EU/EEA
(EUCTR)
01/04/2015Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and SafetyTreatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Pharmacia & Upjohn S.A.NULLNAFemale: yes
Male: yes
30France
3EUCTR2014-004105-32-Outside-EU/EEA
(EUCTR)
01/04/2015Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid TherapyPrevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor (Genotonorm) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-Term Corticosteroid Therapy. Extension of the Study Beyond Three Years. Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Pfizer IncNULLNAFemale: yes
Male: yes
21France

187. 歌舞伎症候群


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

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02204163
(ClinicalTrials.gov)
June 201425/7/2014Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi SyndromeA Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi SyndromePrader-Willi SyndromeDrug: Eutropin;Drug: GenotropinLG Life SciencesNULLCompletedN/AN/AAll34Phase 3Korea, Republic of
2EUCTR2011-001313-14-NL
(EUCTR)
17/10/201212/01/2012Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS.Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study Prader Willi Syndrome
MedDRA version: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made.
Product Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: growth hormone
Dutch growth research foundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
3NCT01401244
(ClinicalTrials.gov)
July 14, 201120/7/2011Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult VolunteersA Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult VolunteersGenetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;HealthyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years40 YearsAll30Phase 1United States
4EUCTR2007-004716-31-NL
(EUCTR)
05/03/200806/11/2007Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWSEffects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS Prader-Willi Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
Trade Name: GenotropinDutch Growth FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands