100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC ( 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 | 17 |
299. 嚢胞性線維症
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 | EUCTR2019-000833-37-DE (EUCTR) | 23/01/2020 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Trikafta Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ 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;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2019-000833-37-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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;Germany;Netherlands;United Kingdom;Italy | ||
| 3 | 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 | ||
| 4 | EUCTR2019-000833-37-ES (EUCTR) | 19/11/2019 | 09/08/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | 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;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | 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 | ||
| 6 | EUCTR2019-000833-37-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2019-000833-37-IE (EUCTR) | 21/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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 | Canada;Netherlands;Belgium;United States;Ireland;Denmark;Italy;United Kingdom;Australia;France;Germany;Spain | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2019-000833-37-DK (EUCTR) | 17/10/2019 | 09/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 11 | 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 | France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | 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 | ||
| 13 | EUCTR2019-000833-37-FR (EUCTR) | 02/09/2019 | 12/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 14 | 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 | |||
| 15 | 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 | |||
| 16 | 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 | |||
| 17 | EUCTR2019-000833-37-BE (EUCTR) | 25/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 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;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy |