274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 91 / 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
| 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 | EUCTR2016-005096-27-GB (EUCTR) | 25/08/2017 | 19/02/2018 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo Biopharma 3 Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Denmark;United Kingdom | ||
| 2 | EUCTR2016-005096-27-DK (EUCTR) | 23/06/2017 | 24/03/2017 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion,generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo BioPharma 3 Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Canada;Denmark;United Kingdom |