AMG 785 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 274 | 骨形成不全症 | 4 |
274. 骨形成不全症
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
| 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 | 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 Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | 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] | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 2 | 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 Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | 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] | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 3 | EUCTR2017-004972-74-IT (EUCTR) | 21/10/2020 | 21/01/2021 | 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 Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta - NA | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass, and increased bone turnover contributing to osteoporosis, fractures, and other conditions. OI is the most common form of primary osteoporosis in children 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] | Trade Name: Evenity 105mg Product Name: Romosozumab Product Code: [AMG 785] INN or Proposed INN: ROMOSOZUMAB Trade Name: CALCIUM D3 SANDOZ - 1000 MG + 880 U.I. COMPRESSE EFFERVESCENTI 30 COMPRESSE DIVISIBILI Product Name: Calcium D3 Product Code: [vitamina D e calcio] INN or Proposed INN: CALCIO CARBONATO/COLECALCIFEROLO | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 4 | EUCTR2017-004972-74-HU (EUCTR) | 15/09/2020 | 10/07/2020 | 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 Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | 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] | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy |