78. 下垂体前葉機能低下症
[臨床試験数:462,薬物数:346(DrugBank:45),標的遺伝子数:41,標的パスウェイ数:80

Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
49 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04513171
(ClinicalTrials.gov)
December 26, 20187/8/2020Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency ChildrenA Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.Growth Hormone DeficiencyDrug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: NorditropinXiamen Amoytop Biotech Co., Ltd.Tongji HospitalRecruiting3 Years11 YearsAll400Phase 2;Phase 3China
2EUCTR2017-003410-20-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
400Phase 3United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany
3ChiCTR1800017144
2018-07-252018-07-13A diverse response study of Pegylated Somatropin to treat growth hormone deficiency childrenA diverse response study of Pegylated Somatropin to treat growth hormone deficiency children Growth hormone deficiencyTwo groups:low dose versus high dose of Pegylated Somatropin;The Children's Hospital, Zhejiang University School of MedicineNULLRecruiting314BothTwo groups:900;China‘
4EUCTR2017-003410-20-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
5EUCTR2017-003410-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001145-11-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
7EUCTR2016-001145-11-IT
(EUCTR)
07/04/201710/01/2017A 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: 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
INN or Proposed INN: Sterile Water
Other descriptive name: STERILISED WATER FOR INJECTIONS
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3South Africa;Lithuania;Turkey;United Kingdom;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden
8NCT03104010
(ClinicalTrials.gov)
April 201728/3/2017A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHDA Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: Somatropin InjectionGeneScience Pharmaceuticals Co., Ltd.Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China HospitalRecruiting18 Years60 YearsAll180Phase 2China
9EUCTR2016-001145-11-PL
(EUCTR)
31/03/201717/01/2017A 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
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
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Belarus;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
10NCT03290235
(ClinicalTrials.gov)
March 1, 201719/9/2017Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenThe Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenGrowth RetardationDrug: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting42 Months15 YearsAll1500Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03249480
(ClinicalTrials.gov)
January 201524/7/2017Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's HospitalRecruiting3 Years18 YearsAll900Phase 4China
12NCT02976675
(ClinicalTrials.gov)
January 201524/11/2016Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong UniversityRecruiting3 Years18 YearsAll600Phase 4China
13NCT02380235
(ClinicalTrials.gov)
December 20142/3/2015Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)Growth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 Years18 YearsAll600Phase 4China
14NCT02314676
(ClinicalTrials.gov)
November 201427/11/2014Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenDwarfism, PituitaryBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.NULLRecruiting3 YearsN/ABoth900Phase 4China
15NCT02908958
(ClinicalTrials.gov)
November 201419/9/2016Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone DeficiencyClinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial IIGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second HospitalRecruiting3 Years18 YearsAll900Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-002787-27-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
17EUCTR2012-002787-27-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
18EUCTR2012-002787-27-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
19EUCTR2012-002787-27-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
20EUCTR2012-002787-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2012-002787-27-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
22NCT01804413
(ClinicalTrials.gov)
March 201118/2/2013Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone DeficiencyEffects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot StudyAdults Growth Hormone Deficiency.Drug: Pegvisomant;Drug: Regular insulinOregon Health and Science UniversityAarhus University HospitalRecruiting21 Years55 YearsBoth10N/AUnited States
23NCT01613573
(ClinicalTrials.gov)
March 20101/6/2012Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenA Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenGrowth Hormone DeficiencyDrug: somatropin AQ;Drug: pegylated somatropinGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and TechnologyCompleted4 Years10 YearsMale12Phase 1NULL
24EUCTR2008-008240-25-ES
(EUCTR)
04/11/200910/08/2009Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient childrenEnsayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom;Denmark;Slovenia;France;Spain
25EUCTR2008-008240-25-DK
(EUCTR)
12/10/200917/08/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Slovenia;Denmark;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2008-008240-25-GB
(EUCTR)
01/10/200918/06/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain
27EUCTR2008-008240-25-FR
(EUCTR)
02/09/200910/04/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom;Denmark;Slovenia;France;Spain
28NCT00936403
(ClinicalTrials.gov)
August 20099/7/2009A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth HormoneA Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient ChildrenGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: NNC126-0083;Drug: somatropinNovo Nordisk A/SNULLCompleted6 Years12 YearsAll31Phase 2Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom
29EUCTR2008-008240-25-BE
(EUCTR)
10/06/200924/04/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32France;Slovenia;Spain;Belgium;Denmark;United Kingdom
30EUCTR2008-008240-25-SI
(EUCTR)
25/05/200906/05/2009A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childrenA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children growth hormone deficiency (GHD) in children
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: NNC 126-0083
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Denmark;Slovenia;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2007-001746-40-HU
(EUCTR)
25/08/200802/04/2007A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: ARX201
Other descriptive name: Pegylated recombinant human growth hormone
Ambrx, Inc., USANULLNot RecruitingFemale: yes
Male: yes
45Phase 2bHungary
32EUCTR2008-001061-29-DK
(EUCTR)
17/06/200829/04/2008A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) Growth hormone deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: NN8630
Product Code: NNC 126-0083
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
32Denmark
33EUCTR2005-005587-82-GR
(EUCTR)
28/11/200728/06/2007A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LtdNULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
34EUCTR2005-005587-82-PL
(EUCTR)
07/07/200731/05/2007A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
35NCT01495468
(ClinicalTrials.gov)
March 200716/12/2011Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenPegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical TrialGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin UniversityCompleted8 Years15 YearsAll343Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2005-005587-82-CZ
(EUCTR)
15/02/200725/10/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Netherlands;Denmark;Italy;Greece;Poland;Sweden
37EUCTR2005-005587-82-NL
(EUCTR)
08/08/200612/05/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
PfizerPfizerNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
38EUCTR2005-005593-79-BE
(EUCTR)
31/07/200611/05/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer N.V./S.A.NULLNot RecruitingFemale: yes
Male: yes
32Spain;Belgium;Germany;United Kingdom
39EUCTR2005-005587-82-BE
(EUCTR)
03/07/200622/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer NV/SANULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Greece;Poland;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
40EUCTR2005-005587-82-DE
(EUCTR)
21/06/200606/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;Greece;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2005-005587-82-SE
(EUCTR)
12/06/200602/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer AB;Pfizer LtdNot RecruitingFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
42EUCTR2005-005593-79-DE
(EUCTR)
09/06/200603/04/2006A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Germany;Spain
43EUCTR2005-005593-79-GB
(EUCTR)
02/06/200621/03/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/AA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
32Germany;United Kingdom;Spain
44EUCTR2005-005593-79-ES
(EUCTR)
31/05/200604/04/2006A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiencyA Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency Paediatric Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Code: PHA-794428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Code: PHA-794428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Germany;United Kingdom;Spain
45EUCTR2005-005587-82-GB
(EUCTR)
17/05/200620/04/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Code: PHA-794,428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Code: PHA-794,428
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01342146
(ClinicalTrials.gov)
May 200621/4/2011Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency ChildrenEfficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 StudyGrowth Hormone DeficiencyDrug: pegylated Somatropin;Drug: Jintropin AQGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan UniversityCompletedN/AN/AAll101Phase 2NULL
47EUCTR2005-005587-82-DK
(EUCTR)
26/04/200615/03/2006A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/AA Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A Adult Growth Hormone Deficiency
MedDRA version: 8.1;Level: LLT;Classification code 10056438
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Product Name: N/A
Product Code: PHA-794,428
INN or Proposed INN: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
136Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
48NCT00468624
(ClinicalTrials.gov)
December 20042/5/2007Effect of Pegvisomant on GH/IGF-I Relationship in GHDA Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD)Severe Adult Growth Hormone DeficiencyDrug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limbChristie Hospital NHS Foundation TrustNULLTerminated18 Years70 YearsBothN/AUnited Kingdom
49EUCTR2012-002787-27-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