Human Serum Albumin (HSA) fused to somatropin ( DrugBank: Somatropin, Human serum albumin, Serum albumin )


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
1EUCTR2013-004468-69-PL
(EUCTR)
28/05/201505/02/2015A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
2EUCTR2013-004468-69-BG
(EUCTR)
18/02/201507/10/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
3EUCTR2013-004468-69-ES
(EUCTR)
22/01/201503/11/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
4EUCTR2013-004468-69-CZ
(EUCTR)
08/08/201411/04/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Growth hormone deficiency
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
5EUCTR2013-004468-69-GR
(EUCTR)
29/07/201416/06/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
6EUCTR2013-004468-69-HU
(EUCTR)
11/06/201421/02/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren Growth hormone deficiency
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia
7EUCTR2012-004975-37-SE
(EUCTR)
05/09/201309/07/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden
8EUCTR2012-004975-37-DE
(EUCTR)
05/08/201302/05/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
9EUCTR2012-004975-37-CZ
(EUCTR)
20/06/201304/01/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
10EUCTR2012-004975-37-SI
(EUCTR)
22/05/201317/04/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden
11EUCTR2012-004975-37-GR
(EUCTR)
27/03/201329/03/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden
12EUCTR2012-004975-37-SK
(EUCTR)
27/02/201304/03/2013A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
13EUCTR2012-004975-37-HU
(EUCTR)
21/01/201323/11/2012A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency Growth hormone deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin®
Product Name: Recombinant human Growth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden
14EUCTR2013-004468-69-RO
(EUCTR)
02/06/2014A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Growth hormone deficiency
MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Albutropin
Product Code: TV1106
INN or Proposed INN: Albutropin
Other descriptive name: human Serum Albumin (HSA) fused to somatropin
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Albutropin
Other descriptive name: Human Serum Albumin (HSA) fused to somatropin
Trade Name: Genotropin
Product Name: Recombinant Human Gowth Hormone
Product Code: n/a
INN or Proposed INN: somatropin
Other descriptive name: SOMATROPIN
Teva Pharmaceutical Industries, Ltd.NULLNAFemale: yes
Male: yes
60Phase 2Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia