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
Showing 1 to 10 of 91 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 | NCT05559801 (ClinicalTrials.gov) | March 2023 | 8/9/2022 | Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI) | A Phase 1/2 Study to Examine the Safety and Preliminary Efficacy of Mesenchymal Stromal Cells on Linear Growth and Bone Health Parameters in Children With Type 3 Osteogenesis Imperfecta (OI) A Phase 1/2 Study to Examine the Safety and Preliminary Efficacy of Mesenchymal Stromal Cells on Lin ... | Osteogenesis Imperfecta;Osteogenesis Imperfecta Type III | Drug: Bone marrow-derived mesenchymal stromal cells (MSCs) | Emory University | NULL | Not yet recruiting | 3 Years | 10 Years | All | 12 | Phase 1/Phase 2 | NULL |
| 2 | NCT05231668 (ClinicalTrials.gov) | August 25, 2022 | 31/1/2022 | Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI) | A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Activity of SAR439459 in Adults With Osteogenesis Imperfecta A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerabili ... | Osteogenesis Imperfecta | Drug: SAR439459;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 65 Years | All | 24 | Phase 1 | United States;Australia;Canada;France |
| 3 | NCT05321199 (ClinicalTrials.gov) | May 2022 | 11/3/2022 | Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta | Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail Application in Osteogenesis Imperfecta - Randomized Control Trials Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail App ... | Osteogenesis Imperfecta | Drug: Tranexamic acid | Assiut University | NULL | Not yet recruiting | N/A | N/A | All | 20 | N/A | NULL |
| 4 | NCT05312697 (ClinicalTrials.gov) | April 28, 2022 | 28/3/2022 | Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta | A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV O ... | Osteogenesis Imperfecta | Biological: Setrusumab | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Terminated | 19 Years | 80 Years | All | 2 | Phase 2 | United States |
| 5 | NCT05125809 (ClinicalTrials.gov) | February 21, 2022 | 8/11/2021 | Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta ... | An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Eva ... | Osteogenesis Imperfecta | Biological: Setrusumab;Other: Placebo | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Recruiting | 5 Years | 25 Years | All | 219 | Phase 2/Phase 3 | United States;Argentina;Australia;Canada;France;Germany;Italy;Netherlands;Poland;Portugal;Turkey;United Kingdom;Denmark United States;Argentina;Australia;Canada;France;Germany;Italy;Netherlands;Poland;Portugal;Turkey;Uni ... |
| 6 | EUCTR2017-004972-74-DE (EUCTR) | 20/07/2021 | 22/07/2020 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and ... | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta(OI) is a group of genetic skeletal disorderscharacterized by increased bone ... | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name ... | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 7 | EUCTR2017-004972-74-GR (EUCTR) | 19/02/2021 | 18/12/2020 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and ... | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta(OI) is a group of genetic skeletal disorderscharacterized by increased bone ... | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name ... | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 8 | NCT04545554 (ClinicalTrials.gov) | January 21, 2021 | 4/9/2020 | Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | Osteogenesis Imperfecta | Drug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin D | Amgen | NULL | Active, not recruiting | 5 Years | 17 Years | All | 25 | Phase 1 | United States;Austria;Germany;Greece;Hungary;Italy;Spain;Turkey |
| 9 | EUCTR2016-003228-22-NL (EUCTR) | 13/01/2021 | 27/11/2020 | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study | 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: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | Trade Name: Teriparatide Product Name: Teriparatide Trade Name: Zoledronic acid Product Name: Zoledronic acid Trade Name: Alendronic acid Product Name: Alendronic acid Trade Name: Risedronate sodium Product Name: Risedronate sodium Trade Name: Ibandronic acid Product Name: Ibandronic acid Trade Name: Ibandronic acid Product Name: Ibandronic acid Trade Name: Disodium Pamidronate 15mg (15mg strength) Product Name: Disodium Pamidronate 15mg (15mg strength) Trade Name: Prolia Product Name: Prolia Trade Name: Bonefos Product Name: Bonefos Trade Name: Teriparatide Product Name: Teriparatide Trade Name: Zoledronic acid Product Name: Zoledroni ... | University of Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 10 | 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 Denosumab in Childr ... | 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: Osteog ... | 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 ... |