274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 87 / 薬物数 : 103 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76
Showing 1 to 10 of 25 diseases
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 | EUCTR2018-000550-21-BG (EUCTR) | 01/12/2020 | 11/09/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ... | ||
2 | EUCTR2014-000184-40-PL (EUCTR) | 13/10/2020 | 15/01/2015 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumabin Children With Osteogenesis I ... | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Den ... | 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] Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium ... | ||
3 | EUCTR2018-000550-21-DE (EUCTR) | 18/09/2020 | 20/02/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ... | ||
4 | EUCTR2018-000550-21-CZ (EUCTR) | 31/03/2020 | 14/02/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ... | ||
5 | EUCTR2018-000550-21-ES (EUCTR) | 01/10/2019 | 05/07/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ... | ||
6 | EUCTR2018-000550-21-IT (EUCTR) | 21/06/2019 | 15/06/2021 | Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfecta Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumabin Children ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - NA Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: [AMG 162] INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: [AMG 162] INN or Proposed INN: Denosumab Other d ... | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgiu ... | ||
7 | EUCTR2018-000550-21-GB (EUCTR) | 07/03/2019 | 17/06/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ... | ||
8 | NCT03638128 (ClinicalTrials.gov) | July 26, 2018 | 21/6/2018 | Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Curren ... | Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) | Drug: Denosumab;Other: No treatment;Drug: Alternative osteoporosis medications | Amgen | NULL | Active, not recruiting | 5 Years | 20 Years | All | 75 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United King ... |
9 | EUCTR2018-000550-21-HU (EUCTR) | 06/07/2018 | 10/05/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumabin Childre ... | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | Osteogenesis Imperfecta (OI) 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] Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Austral ... | ||
10 | NCT02352753 (ClinicalTrials.gov) | June 24, 2015 | 28/1/2015 | Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumabin Childre ... | To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI To Evaluate the Effect of Denosumabin Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, ... | Osteogenesis Imperfecta | Drug: Denosumab | Amgen | NULL | Active, not recruiting | 2 Years | 17 Years | All | 153 | Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Un ... |