RhGH ( DrugBank: rhGH )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
76下垂体性ゴナドトロピン分泌亢進症2
78下垂体前葉機能低下症83
96クローン病1
193プラダー・ウィリ症候群3

76. 下垂体性ゴナドトロピン分泌亢進症


臨床試験数 : 28 薬物数 : 46 - (DrugBank : 14) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 19
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1800017120
2018-08-012018-07-12A real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girlsA real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls. precocious pubertyCase series:rhGH therapy;The Children's Hospital, Zhejiang University School of MedicineNULLRecruiting312FemaleCase series:700;China
2ChiCTR1800016768
2018-06-252018-06-22A real world study on the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girlsA real world study on the efficacy and safety of the combination therapy of GnRHa and rhGH in the treatment of central precocious puberty or rapid progressive adolescent girls Central precocious puberty or rapid progressive adolescenceCase series:GnRHa combined with rhGH;The Children's Hospital, Zhe Jiang University School of MedcineNULLRecruiting612FemaleCase series:700;China

78. 下垂体前葉機能低下症


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05250063
(ClinicalTrials.gov)
February 18, 202210/2/2022Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial LUM-201-01 Trial (OraGrowtH213 Trial)A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 TrialGrowth Hormone DeficiencyDrug: LUM-201Lumos PharmaNULLEnrolling by invitation3 Years13 YearsAll20Phase 2United States
2NCT04614337
(ClinicalTrials.gov)
December 31, 202026/10/2020Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: LUM-201;Drug: rhGH Norditropin® pen (34 µg/kg)Lumos PharmaNULLRecruiting3 Years12 YearsAll80Phase 2United States;Australia;Israel;New Zealand;Poland;Russian Federation;Ukraine
3NCT03104010
(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
4EUCTR2014-004525-41-PL
(EUCTR)
09/03/201623/02/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH.Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY Growth hormone deficiency
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: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Belgium;Poland;Netherlands;Sweden
5EUCTR2014-002736-13-PL
(EUCTR)
08/01/201629/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
6EUCTR2014-003796-32-PL
(EUCTR)
08/01/201629/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Lithuania;Austria;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany
7EUCTR2014-002736-13-HR
(EUCTR)
09/12/201501/02/2016A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
8EUCTR2014-003796-32-HR
(EUCTR)
04/12/201501/02/2016A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
9EUCTR2014-003796-32-RO
(EUCTR)
18/11/201508/10/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
10EUCTR2014-002736-13-SI
(EUCTR)
15/10/201512/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
11EUCTR2014-003796-32-SI
(EUCTR)
15/10/201512/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
12EUCTR2005-000384-26-FR
(EUCTR)
12/10/201504/10/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
138 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
13EUCTR2014-003796-32-BG
(EUCTR)
07/10/201502/10/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
14EUCTR2014-002736-13-CZ
(EUCTR)
01/10/201510/09/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
15EUCTR2014-003796-32-CZ
(EUCTR)
01/10/201514/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
16EUCTR2014-004525-41-NL
(EUCTR)
03/09/201523/03/2015A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH.Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY 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: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
17EUCTR2014-003796-32-IT
(EUCTR)
25/08/201527/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
18EUCTR2014-002736-13-IT
(EUCTR)
25/08/201527/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
19NCT02339090
(ClinicalTrials.gov)
August 24, 20157/1/2015Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency.Growth DisordersDrug: somavaratan;Drug: Daily rhGHVersartis Inc.NULLCompleted3 Years11 YearsAll136Phase 3Belgium;Canada;Netherlands;Poland;Sweden;United States
20EUCTR2014-003796-32-DE
(EUCTR)
21/08/201516/03/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
21EUCTR2014-002736-13-LT
(EUCTR)
20/08/201514/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
22EUCTR2014-003796-32-LT
(EUCTR)
20/08/201514/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
23EUCTR2014-002736-13-DE
(EUCTR)
19/08/201513/03/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
24EUCTR2014-003796-32-ES
(EUCTR)
31/07/201508/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
25EUCTR2014-002736-13-ES
(EUCTR)
24/07/201508/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
26EUCTR2014-002736-13-HU
(EUCTR)
26/06/201510/04/2015A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) 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: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
27EUCTR2014-002736-13-GR
(EUCTR)
26/06/201510/06/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden;Lithuania;Austria;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey
28EUCTR2014-003796-32-HU
(EUCTR)
26/06/201510/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
29EUCTR2014-003796-32-GR
(EUCTR)
22/06/201515/06/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
30EUCTR2014-002736-13-AT
(EUCTR)
22/06/201504/05/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
31EUCTR2014-003796-32-AT
(EUCTR)
22/06/201529/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
32EUCTR2014-002736-13-SE
(EUCTR)
25/05/201521/04/2015A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
33EUCTR2014-003796-32-SK
(EUCTR)
20/05/201515/01/2016A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
34EUCTR2014-002736-13-SK
(EUCTR)
20/05/201515/01/2016A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®)A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency 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: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Trade Name: Genotropin
Product Name: Somatropin; Recombinant Human Gowth Hormone
Product Code: Not applicable
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
35NCT02410343
(ClinicalTrials.gov)
April 30, 201530/3/2015Study of TV-1106 in Growth Hormone-Deficient AdultsA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH TreatmentGrowth Hormone DeficiencyDrug: TV-1106;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 YearsN/AAll14Phase 3Hungary;Italy;Russian Federation;United States;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Serbia;Slovakia;Slovenia;Spain;Turkey;Ukraine;Austria;Czechia;Greece
36NCT02410356
(ClinicalTrials.gov)
April 30, 201530/3/2015A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyA Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: dGHTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 YearsN/AAll34Phase 3United States;Austria;Czechia;Greece;Hungary;Italy;Slovakia;Spain;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey;Ukraine
37EUCTR2014-004525-41-BE
(EUCTR)
22/04/201516/02/2015A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY 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: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Poland;Belgium;Netherlands;Sweden
38EUCTR2014-004525-41-SE
(EUCTR)
10/04/201512/02/2015A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGHComparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY 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: Somavaratan (VRS-317)
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinat human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Poland;Belgium;Netherlands;Sweden
39EUCTR2011-001826-61-BG
(EUCTR)
07/02/201412/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
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: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
40EUCTR2012-002787-27-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
41EUCTR2012-002787-27-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
42NCT01947907
(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
43EUCTR2012-002787-27-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
44EUCTR2012-002787-27-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
45EUCTR2012-002787-27-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
46EUCTR2012-002787-27-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
47EUCTR2011-001826-61-PL
(EUCTR)
25/01/201212/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
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: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
48NCT01822340
(ClinicalTrials.gov)
October 201125/3/2013Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency PatientsA Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyDrug: HM10560A;Drug: GenotropinHanmi Pharmaceutical Company LimitedNULLCompleted23 Years60 YearsBoth72Phase 2Hungary;Romania
49EUCTR2011-001826-61-HU
(EUCTR)
29/07/201123/05/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) Adult growth hormone deficiency (AGHD)
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: HM10560A
Product Code: HM10560A
Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
Trade Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Hanmi Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
50EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
51EUCTR2010-020742-10-ES
(EUCTR)
01/04/201107/01/2011Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplicaTratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Finland;United Kingdom;Spain;Sweden
52EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
53EUCTR2010-019374-32-AT
(EUCTR)
15/02/201129/12/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Only medicinal products registered in Austria will be used in this clinical trial.
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany
54EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
55EUCTR2010-019374-32-SI
(EUCTR)
13/09/201004/06/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Omnitrop
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: ecombinanat DNA-derived human growth h
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
56EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
57EUCTR2010-019374-32-CZ
(EUCTR)
06/09/201015/06/2010A study with MOD-4023 in patients with lack of Growth Hormone in the bodyA Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 14.0;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
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Prolor Biotech LtdNULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel
58EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Genotropin
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli
Trade Name: Humatrope
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Norditropin Simplex
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: Saizen
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli
Trade Name: NutropinAq
Product Name: recombinant human Growth Hormone(rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinanat DNA-derived human growth
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
59NCT01605331
(ClinicalTrials.gov)
December 200922/5/2012Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)Growth Hormone DeficiencyDrug: sustained-release recombinant human GH (SR-rhGH)LG Life SciencesNULLCompleted20 YearsN/ABoth132Phase 4NULL
60NCT00684957
(ClinicalTrials.gov)
January 200823/5/2008Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk FactorsDifferential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1Columbia UniversityTercicaTerminated25 Years65 YearsMale5N/AUnited States
61EUCTR2006-002278-24-SE
(EUCTR)
15/05/200705/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
62EUCTR2006-002278-24-GB
(EUCTR)
02/05/200723/11/2006 A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
63EUCTR2006-002278-24-SK
(EUCTR)
20/04/200722/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
64EUCTR2006-002278-24-FR
(EUCTR)
13/04/200724/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
65EUCTR2006-002278-24-AT
(EUCTR)
05/01/200710/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
66EUCTR2005-000346-36-LT
(EUCTR)
29/12/200624/10/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania
67EUCTR2006-002278-24-CZ
(EUCTR)
14/12/200608/09/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
68EUCTR2006-002278-24-ES
(EUCTR)
13/12/200610/03/2010Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
69EUCTR2006-002278-24-DE
(EUCTR)
06/10/200615/08/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
70EUCTR2005-000384-26-DE
(EUCTR)
20/12/200502/06/2006A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;Spain;Sweden
71EUCTR2005-000384-26-AT
(EUCTR)
10/11/200510/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.BioPartnersNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden
72EUCTR2005-000384-26-SK
(EUCTR)
27/10/200519/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
73EUCTR2005-000384-26-GB
(EUCTR)
21/10/200517/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
74EUCTR2005-000384-26-CZ
(EUCTR)
30/09/200508/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
75EUCTR2005-000346-36-FI
(EUCTR)
22/09/200530/05/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
76EUCTR2005-000384-26-SE
(EUCTR)
13/09/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
77EUCTR2005-000384-26-ES
(EUCTR)
22/08/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimientoA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
138Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
78EUCTR2005-000346-36-SE
(EUCTR)
18/08/200516/06/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
79EUCTR2005-000346-36-DE
(EUCTR)
16/08/200506/06/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
80NCT00458991
(ClinicalTrials.gov)
June 20019/4/2007rhGH Therapy on Hepatic Drug MetabolismRecombinant Human Growth Hormone Therapy and Drug MetabolismGrowth Hormone Deficiency, DwarfismDrug: Dextromethorphan and CaffeineUniversity of LouisvilleEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed4 Years14 YearsAll9N/AUnited States
81NCT00497484
(ClinicalTrials.gov)
February 19955/7/2007Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)Pseudohypoparathyroidism;Growth Hormone Deficiency, DwarfismDrug: recombinant human somatotropinUniversity of MilanEli Lilly and CompanyActive, not recruiting1 Year18 YearsBothN/AItaly
82EUCTR2010-019374-32-DE
(EUCTR)
07/12/2010A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: n/a
Product Code: MOD-4023
Trade Name: Only medicinal products registered in Germany will be used in this clinical trial
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
ModigeneTech Ltd.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Czech Republic;Slovakia;Germany;Slovenia
83EUCTR2012-002787-27-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

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022215-19-GB
(EUCTR)
21/07/201123/06/2011Combined growth hormone and IGF1 therapy in paediatric Crohn'd diseaseA Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s Impaired growth in Paediatric Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
Other descriptive name: Recombinant human Insulin-like Growth Factor
Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
INN or Proposed INN: Somatropin(rhGH)
Other descriptive name: recombinant growth hormone
Greater Glasgow & Clyde NHSNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100046551
2021-05-182021-05-21Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatmentApplication of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome Prader-Willi sydromePrader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none;Cai JinhuaNULLRecruiting016BothPrader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40;N/AChina
2ChiCTR1900027464
2019-12-012019-11-14Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone ageEfficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age Prader-Willi syndromecontrol group:Single rhGH therapy;observation group:Anastrazole combined with growth hormone therapy;Children's Hospital of Zhejiang University School of MedicineNULLPendingMalecontrol group:20;observation group:20;Phase 4China
3NCT03554031
(ClinicalTrials.gov)
April 14, 201830/5/2018A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromeA Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Recombinant Human Growth Hormone (rhGH) InjectionGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of MedicineUnknown status1 Month5 YearsAll30Phase 3China