272. 進行性骨化性線維異形成症 Fibrodysplasia ossificans progressiva Clinical trials / Disease details
臨床試験数 : 39 / 薬物数 : 38 - (DrugBank : 7) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 95
| 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 | EUCTR2021-002244-70-SE (EUCTR) | 25/10/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: IPN60120 INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Ipsen Pharma | NULL | NA | Female: yes Male: yes | 61 | Phase 3 | France;United States;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden | |||
| 2 | EUCTR2021-002244-70-FR (EUCTR) | 09/11/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: IPN60120 INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Ipsen Pharma SAS | NULL | NA | Female: yes Male: yes | 87 | Phase 3 | United States;France;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden |