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 | EUCTR2015-002677-38-BE (EUCTR) | 11/05/2016 | 03/03/2016 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2015-002677-38-DE (EUCTR) | 09/05/2016 | 03/11/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2015-002677-38-IT (EUCTR) | 06/04/2016 | 25/11/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2015-002677-38-GB (EUCTR) | 04/02/2016 | 27/10/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Germany;Italy;United Kingdom |