TransCon hGH ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
78下垂体前葉機能低下症15

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_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
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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
2NCT04326374
(ClinicalTrials.gov)
December 30, 201926/3/2020Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone DeficiencyThe Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in ChinaGrowth Hormone Deficiency;Endocrine System Diseases;Hormones;Pituitary Diseases;Pituitary Disease, AnteriorDrug: TransCon hGH;Drug: daily hGHVisen Pharmaceuticals (Shanghai) Co., Ltd.Ascendis Pharma A/SRecruiting3 Years17 YearsAll150Phase 3China
3EUCTR2017-003410-20-IT
(EUCTR)
30/10/201811/10/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany
4EUCTR2017-003410-20-PL
(EUCTR)
23/10/201808/11/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany
5EUCTR2017-003410-20-GR
(EUCTR)
04/06/201819/04/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand
6EUCTR2017-003410-20-BG
(EUCTR)
20/04/201809/01/2018A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenenliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Product Name: TransCon hGH (ACP-011)
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand
7EUCTR2016-001145-11-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
8NCT03344458
(ClinicalTrials.gov)
December 19, 201714/11/2017A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical TrialenliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical TrialGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma A/SNULLActive, not recruiting1 Year18 YearsAll300Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine
9NCT03305016
(ClinicalTrials.gov)
November 13, 20174/10/2017A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone DeficiencyfliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHDGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma Endocrinology Division A/SNULLCompleted6 Months17 YearsAll146Phase 3United States;Australia;Canada;New Zealand
10EUCTR2016-001145-11-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
11EUCTR2016-001145-11-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
12EUCTR2016-001145-11-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
13NCT02781727
(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
14NCT01247675
(ClinicalTrials.gov)
November 201023/11/2010A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone DeficiencyA Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyDrug: ACP-001 (TransCon hGH);Drug: OmnitropeAscendis Pharma A/SNULLCompleted20 Years70 YearsAll37Phase 2Denmark;Germany;Italy;Sweden
15EUCTR2016-001145-11-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