VX-659/TEZ/IVA ( DrugBank: VX-659 )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 13 |
299. 嚢胞性線維症
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | NCT03633526 (ClinicalTrials.gov) | August 3, 2018 | 27/7/2018 | Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 6 Years | 11 Years | All | 18 | Phase 3 | United States |
| 2 | EUCTR2017-004133-82-ES (EUCTR) | 18/05/2018 | 15/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Germany;Australia;Ireland;Spain;United States | ||
| 3 | EUCTR2017-004132-11-ES (EUCTR) | 18/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 4 | EUCTR2017-004132-11-DK (EUCTR) | 08/05/2018 | 02/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 5 | EUCTR2017-004133-82-GB (EUCTR) | 02/05/2018 | 14/06/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 6 | EUCTR2017-004132-11-GB (EUCTR) | 02/05/2018 | 23/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom | ||
| 7 | EUCTR2017-004133-82-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 8 | NCT03460990 (ClinicalTrials.gov) | May 1, 2018 | 1/3/2018 | A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 116 | Phase 3 | United States;Australia;Germany;Ireland;Spain;United Kingdom |
| 9 | EUCTR2017-004132-11-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 10 | EUCTR2017-004132-11-DE (EUCTR) | 25/04/2018 | 27/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland | ||
| 11 | NCT03447249 (ClinicalTrials.gov) | March 7, 2018 | 21/2/2018 | A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 385 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 12 | EUCTR2017-004132-11-PL (EUCTR) | 18/04/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| 13 | EUCTR2017-004133-82-DE (EUCTR) | 08/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | 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/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR 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 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom |