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 | EUCTR2014-004788-18-BE (EUCTR) | 03/06/2016 | 03/03/2016 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 18.1;Level: PT;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 2 | EUCTR2014-004788-18-DE (EUCTR) | 24/07/2015 | 31/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 3 | EUCTR2014-004788-18-IT (EUCTR) | 15/07/2015 | 19/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 17.1;Level: PT;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 4 | EUCTR2014-004788-18-NL (EUCTR) | 10/07/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2014-004788-18-GB (EUCTR) | 08/06/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom |