299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | EUCTR2018-003831-31-ES (EUCTR) | 24/01/2020 | 02/12/2019 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs | Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2 | AzurRx | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Poland;Spain | ||
| 2 | EUCTR2018-003831-31-PL (EUCTR) | 01/12/2020 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs | Exocrine Pancreatic Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2 | AzurRx SAS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Spain;Poland;Turkey |