VRS-317 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 16 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03145831 (ClinicalTrials.gov) | March 31, 2017 | 5/4/2017 | A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency | An Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somavaratan | Versartis Inc. | NULL | Terminated | 3 Years | N/A | All | 21 | Phase 3 | United States;Japan |
| 2 | EUCTR2016-002780-34-PL (EUCTR) | 30/01/2017 | 08/11/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Canada;Belgium;Poland;Sweden | ||
| 3 | EUCTR2016-002780-34-BE (EUCTR) | 16/12/2016 | 19/09/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Canada;Poland;Belgium;Sweden | ||
| 4 | EUCTR2016-002780-34-SE (EUCTR) | 10/11/2016 | 13/09/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Canada;Poland;Belgium;Sweden | ||
| 5 | EUCTR2014-004525-41-PL (EUCTR) | 09/03/2016 | 23/02/2016 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Belgium;Poland;Netherlands;Sweden | ||
| 6 | NCT02719990 (ClinicalTrials.gov) | February 9, 2016 | 16/3/2016 | Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD | An 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: somavaratan | Versartis Inc. | Premier Research Group plc | Terminated | 18 Years | 75 Years | All | 34 | Phase 2 | Australia;United States |
| 7 | EUCTR2015-002072-24-DE (EUCTR) | 22/10/2015 | 12/08/2015 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Australia;Germany;United Kingdom | ||
| 8 | EUCTR2014-004525-41-NL (EUCTR) | 03/09/2015 | 23/03/2015 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 9 | NCT02339090 (ClinicalTrials.gov) | August 24, 2015 | 7/1/2015 | Versartis Long-Acting Growth Hormone 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. | Growth Disorders | Drug: somavaratan;Drug: Daily rhGH | Versartis Inc. | NULL | Completed | 3 Years | 11 Years | All | 136 | Phase 3 | Belgium;Canada;Netherlands;Poland;Sweden;United States |
| 10 | NCT02413138 (ClinicalTrials.gov) | August 8, 2015 | 23/3/2015 | Versartis 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 Disorders | Drug: Somavaratan (VRS-317) | Versartis Inc. | NULL | Terminated | 3 Years | 10 Years | All | 41 | Phase 2/Phase 3 | Japan |
| 11 | NCT02526420 (ClinicalTrials.gov) | July 2015 | 13/8/2015 | Versartis International Trial in Adults With Long-Acting Growth Hormone | An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD) | Adult Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | Premier Research Group plc | Completed | 23 Years | 70 Years | Both | 36 | Phase 2 | United States;Australia;Germany;United Kingdom |
| 12 | EUCTR2014-004525-41-BE (EUCTR) | 22/04/2015 | 16/02/2015 | A 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 13 | EUCTR2014-004525-41-SE (EUCTR) | 10/04/2015 | 12/02/2015 | A 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 14 | NCT02068521 (ClinicalTrials.gov) | March 3, 2014 | 6/2/2014 | Versartis Long-Term Safety Study of Somavaratan | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | NULL | Terminated | 3 Years | N/A | All | 385 | Phase 2/Phase 3 | United States |
| 15 | NCT01718041 (ClinicalTrials.gov) | October 2012 | 19/10/2012 | Versartis Trial in Children to Assess Long-Acting Growth Hormone | A Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children With Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy After Subcutaneous Administration for 6 Months | Pediatric Growth Hormone Deficiency | Drug: Experimental: VRS-317 | Versartis Inc. | NULL | Completed | 3 Years | 11 Years | Both | 64 | Phase 1/Phase 2 | United States |
| 16 | NCT01359488 (ClinicalTrials.gov) | March 2011 | 13/5/2011 | VRS-317 in Adult Subjects With Growth Hormone Deficiency | A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: VRS-317 | Versartis Inc. | NULL | Completed | 25 Years | 65 Years | Both | 50 | Phase 1 | United States |