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 | EUCTR2018-003970-28-NL (EUCTR) | 12/09/2019 | 09/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2018-003970-28-DE (EUCTR) | 12/08/2019 | 21/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2018-002496-18-NL (EUCTR) | 08/07/2019 | 13/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Germany;Netherlands;United Kingdom | ||
| 4 | EUCTR2018-003970-28-BE (EUCTR) | 04/07/2019 | 23/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2018-003970-28-GB (EUCTR) | 18/06/2019 | 17/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 6 | EUCTR2018-002496-18-PT (EUCTR) | 20/05/2019 | 05/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Netherlands;Germany;United Kingdom | ||
| 7 | EUCTR2018-002496-18-DE (EUCTR) | 02/05/2019 | 28/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Netherlands;Germany;United Kingdom | ||
| 8 | NCT03912233 (ClinicalTrials.gov) | April 30, 2019 | 10/4/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 87 | Phase 2 | United States;Germany;Netherlands;Portugal;United Kingdom |
| 9 | NCT03911713 (ClinicalTrials.gov) | April 17, 2019 | 9/4/2019 | A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-561;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom |
| 10 | EUCTR2018-002496-18-GB (EUCTR) | 08/03/2019 | 30/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Portugal;United States;Netherlands;Germany;United Kingdom | ||
| 11 | EUCTR2017-000797-11-BE (EUCTR) | 28/08/2017 | 15/06/2017 | A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | Cystic fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: VX-561 Other descriptive name: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 2 | United States;Belgium;Australia;Netherlands | ||
| 12 | EUCTR2016-003585-11-GB (EUCTR) | 10/08/2017 | 10/07/2017 | Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic fibrosis 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] - Respiratory Tract Diseases [C08] | Product Name: VX-659 Product Code: VX-659 INN or Proposed INN: VX-659 Other descriptive name: VX-659 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: Deuterated Ivacaftor Other descriptive name: VX-561 (CTP-656) | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;Ireland;Israel;United Kingdom | ||
| 13 | NCT03224351 (ClinicalTrials.gov) | August 8, 2017 | 18/7/2017 | A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: TEZ/IVA;Drug: VX-659;Drug: IVA;Drug: Matched Placebos;Drug: TEZ;Drug: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 124 | Phase 2 | United States;Ireland;Israel;United Kingdom |
| 14 | NCT03227471 (ClinicalTrials.gov) | January 23, 2017 | 18/7/2017 | A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: IVA;Drug: TEZ/IVA;Drug: VX-445;Drug: Matched Placebo;Drug: TEZ;Drug: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 230 | Phase 1/Phase 2 | United States;Australia;Belgium;Netherlands |
| 15 | NCT02971839 (ClinicalTrials.gov) | December 2016 | 21/11/2016 | Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations | A Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations. | Cystic Fibrosis | Drug: VX-561;Drug: Placebo;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 2 | United States |