Symkevi ( DrugBank: - )
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 | 21 |
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 | EUCTR2018-002835-76-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 2 | EUCTR2018-002835-76-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2018-002835-76-IE (EUCTR) | 21/10/2019 | 28/06/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-002835-76-DE (EUCTR) | 21/10/2019 | 03/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2018-002835-76-DK (EUCTR) | 16/10/2019 | 09/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United Kingdom;Italy;Germany;Netherlands;Denmark;Australia;Ireland;Spain;Belgium;Canada;United States;France | ||
| 6 | EUCTR2018-002835-76-IT (EUCTR) | 04/10/2019 | 12/02/2021 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF)Subjects Heterozygous for F508del and a Gating or Residual FunctionMutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating theEfficacy and Safety of VX-445 Combination Therapy in Subjects With CysticFibrosis Who Are Heterozygous for the F508del Mutation and a Gating orResidual Function Mutation (F/G and F/RF Genotypes) - NA | 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: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: VX-661 / VX-770 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 Other descriptive name: IVA | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2019-001735-31-GB (EUCTR) | 13/09/2019 | 24/06/2019 | A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis | A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2019-001314-41-NL (EUCTR) | 06/05/2019 | 06/05/2019 | This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor. | Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS | Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Orkambi: contains lumacaftor and ivacaftor Product Name: Orkambi Trade Name: Symkevi Product Name: Symkevi Trade Name: Kalydeco Product Name: Kalydeco | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | |||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | EUCTR2017-002968-40-DK (EUCTR) | 28/06/2018 | 24/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | ||
| 14 | EUCTR2017-002968-40-GB (EUCTR) | 28/06/2018 | 07/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 15 | EUCTR2017-002968-40-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 16 | EUCTR2017-002968-40-IE (EUCTR) | 27/04/2018 | 08/03/2018 | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 17 | EUCTR2014-004827-29-GB (EUCTR) | 03/11/2015 | 05/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | 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] | Trade Name: Symkevi Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 18 | EUCTR2017-002968-40-DE (EUCTR) | 05/04/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | 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] | Trade Name: Symdeko Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symdeko Product Name: Ivacaftor 75 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor 150 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 19 | EUCTR2018-002835-76-BE (EUCTR) | 25/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | |||
| 20 | EUCTR2018-002835-76-FR (EUCTR) | 12/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 21 | EUCTR2019-001735-31-BE (EUCTR) | 08/07/2019 | A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis | A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets 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 Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom |