Somavaratan ( DrugBank: Somavaratan )


1 disease
IDDisease name (Link within this page)Number of trials
78Hypopituitarism13

78. Hypopituitarism


Clinical trials : 494 Drugs : 385 - (DrugBank : 49) / Drug target genes : 44 - Drug target pathways : 100
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03145831
(ClinicalTrials.gov)
March 31, 20175/4/2017A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone DeficiencyAn Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomavaratanVersartis Inc.NULLTerminated3 YearsN/AAll21Phase 3United States;Japan
2EUCTR2016-002780-34-PL
(EUCTR)
30/01/201708/11/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan 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: Somavaratan
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Canada;Belgium;Poland;Sweden
3EUCTR2016-002780-34-BE
(EUCTR)
16/12/201619/09/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan 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
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Canada;Poland;Belgium;Sweden
4EUCTR2016-002780-34-SE
(EUCTR)
10/11/201613/09/2016A Long-Acting Growth Hormone (Somavaratan, VRS-317) in ChildrenAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan 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: Somavaratan
Product Code: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
Versartis, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Canada;Poland;Belgium;Sweden
5EUCTR2014-004525-41-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
6NCT02719990
(ClinicalTrials.gov)
February 9, 201616/3/2016Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHDAn Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)Adult Growth Hormone Deficiency (AGHD)Drug: somavaratanVersartis Inc.Premier Research Group plcTerminated18 Years75 YearsAll34Phase 2Australia;United States
7EUCTR2015-002072-24-DE
(EUCTR)
22/10/201512/08/2015A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose.An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD)Versartis International Trial in Adults with Long Acting Growth Hormone. The VITAL study - Versartis International Trial in Adults with Long Acting Growth Hormone (VITAL) Growth Hormone Deficiency in adults
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: Somavaratan
Product Code: VRS-317
INN or Proposed INN: Somavaratan
Other descriptive name: VRS-317
Versartis Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Australia;Germany;United Kingdom
8NCT02339090
(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
9NCT02413138
(ClinicalTrials.gov)
August 8, 201523/3/2015Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)Pediatric Growth Hormone Deficiency;Growth DisordersDrug: Somavaratan (VRS-317)Versartis Inc.NULLTerminated3 Years10 YearsAll41Phase 2/Phase 3Japan
10NCT02526420
(ClinicalTrials.gov)
July 201513/8/2015Versartis International Trial in Adults With Long-Acting Growth HormoneAn Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)Adult Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.Premier Research Group plcCompleted23 Years70 YearsBoth36Phase 2United States;Australia;Germany;United Kingdom
11EUCTR2014-004525-41-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
12EUCTR2014-004525-41-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
13NCT02068521
(ClinicalTrials.gov)
March 3, 20146/2/2014Versartis Long-Term Safety Study of SomavaratanAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.NULLTerminated3 YearsN/AAll385Phase 2/Phase 3United States