78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


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

  
16 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Status
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agemin
Inclusion_
agemax
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PhaseCountries
1EUCTR2011-004553-60-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
2EUCTR2011-004553-60-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
3EUCTR2011-004553-60-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
4NCT01592500
(ClinicalTrials.gov)
February 20122/5/2012Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenSafety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOPKO Health, Inc.NULLCompleted3 Years11 YearsAll56Phase 2Greece;Hungary;Slovakia
5EUCTR2011-004553-60-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
6EUCTR2011-004553-60-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
7EUCTR2011-004553-60-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
8EUCTR2010-023430-23-GB
(EUCTR)
28/03/201124/01/2011A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;Czech Republic;United Kingdom
9EUCTR2010-023430-23-CZ
(EUCTR)
09/02/201125/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
10EUCTR2010-023430-23-HU
(EUCTR)
17/01/201110/11/2010A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: Saizen
Product Name: Saizen
Product Code: NA
INN or Proposed INN: SOMATROPIN
Merck Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Hungary;United Kingdom;Czech Republic
11NCT01237340
(ClinicalTrials.gov)
October 20105/11/2010Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity StudyA Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)Growth Hormone Deficiency (GHD)Drug: Saizen®EMD SeronoNULLTerminated18 Years60 YearsAll59Phase 3United States
12NCT01034735
(ClinicalTrials.gov)
July 200816/12/2009r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence TrialPhase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy VolunteersGrowth Failure;Growth Hormone DeficiencyBiological: r-hGH liquid (Saizen);Biological: r-hGH freeze-driedEMD SeronoNULLCompleted18 Years45 YearsBoth30Phase 1Germany
13NCT01187550
(ClinicalTrials.gov)
March 200722/8/2010Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®Dwarfism, PituitaryDrug: Recombinant human growth hormone (r-hGH)Merck KGaAMerck Serono Co., Ltd., ChinaCompletedN/AN/AAll214Phase 4NULL
14NCT00109733
(ClinicalTrials.gov)
January 20052/5/2005Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone DeficiencyA Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS)Childhood-onset Growth Hormone Deficiency;Pituitary DwarfismBiological: recombinant human growth hormoneEMD SeronoNULLCompleted13 Years25 YearsAll31Phase 3United States
15NCT01157793
(ClinicalTrials.gov)
September 20036/7/2010A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to AdulthoodA Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to AdulthoodDwarfism;Growth Hormone DeficiencyDrug: r-hGHMerck KGaANULLCompleted14 Years25 YearsBoth34Phase 4NULL
16EUCTR2016-000446-56-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