ACP-001 ( 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14

78. 下垂体前葉機能低下症


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 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
1EUCTR2012-002787-27-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
2EUCTR2012-002787-27-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
3NCT01947907
(ClinicalTrials.gov)
July 20133/6/2013Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone Deficiency (GHD)Drug: ACP-001;Drug: Human Growth HormoneAscendis Pharma A/SNULLCompleted3 Years12 YearsAll53Phase 2Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine
4EUCTR2012-002787-27-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
5EUCTR2012-002787-27-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
6EUCTR2012-002787-27-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
7EUCTR2012-002787-27-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
8NCT01247675
(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
9EUCTR2010-021523-28-DE
(EUCTR)
05/10/201010/08/2010A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
10EUCTR2010-021523-28-IT
(EUCTR)
28/09/201027/12/2010A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - NDA phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND Growth Hormone Deficiency
MedDRA version: 9.1;Level: PT;Classification code 10056438
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: OMNITROPE
INN or Proposed INN: Somatropin
ASCENDIS PHARMA A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Germany;Denmark;Italy;Austria;Sweden
11EUCTR2010-021523-28-SE
(EUCTR)
27/09/201006/08/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: Somatropin
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
12EUCTR2010-021523-28-DK
(EUCTR)
13/09/201029/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Austria;Denmark;Germany;Italy;Sweden
13EUCTR2010-021523-28-AT
(EUCTR)
02/09/201020/07/2010A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) Growth Hormone Deficiency
MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: ACP-001
Product Code: ACP-001
INN or Proposed INN: SOMATROPIN
Trade Name: Omnitrope®
INN or Proposed INN: SOMATROPIN
Ascendis Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
14EUCTR2012-002787-27-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