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 | EUCTR2021-005914-33-AT (EUCTR) | 18/08/2022 | 15/06/2022 | Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del | A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del | 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: Kaftrio Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/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 Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden | ||
| 2 | EUCTR2021-000712-31-ES (EUCTR) | 28/03/2022 | 19/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | 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/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor 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 Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2021-000712-31-PT (EUCTR) | 14/01/2022 | 16/11/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del 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-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor 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 Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | ||
| 4 | EUCTR2021-000694-85-IT (EUCTR) | 21/12/2021 | 15/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo | 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: Kalydeco Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: ivacaftor Product Name: VX-121/tezacaftor/deutivacaftor Product Code: [VX-121/TEZ/D-IVA] INN or Proposed INN: tezacaftor INN or Proposed INN: deutivacaftor Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: [ELX/TEZ/IVA] INN or Proposed INN: elexacaftor INN or Proposed INN: tezacaftor INN or Proposed INN: ivacaftor | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 5 | EUCTR2021-000694-85-DE (EUCTR) | 20/12/2021 | 27/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del 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-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor 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 Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 6 | EUCTR2021-000694-85-NL (EUCTR) | 09/12/2021 | 27/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del 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-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor 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 Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 7 | EUCTR2020-004885-21-ES (EUCTR) | 18/11/2021 | 19/10/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in 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] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 | 143 | Phase 3 | Czechia;Czech Republic;Belgium;Spain;Netherlands | ||
| 8 | EUCTR2020-004885-21-CZ (EUCTR) | 12/11/2021 | 31/08/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in 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] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 143 | Phase 3 | Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands | ||
| 9 | EUCTR2020-005224-12-NL (EUCTR) | 01/05/2021 | 04/01/2021 | Kaftrio in cystic fibrosis patients currently using tacrolimus, a drug drug interaction study | Elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study - Kaftac | cystic fibrosis patients;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kaftrio | Haga Teaching Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 4 | Netherlands | ||
| 10 | NCT04602468 (ClinicalTrials.gov) | September 3, 2020 | 20/10/2020 | Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) | Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) | Cystic Fibrosis;Cystic Fibrosis Liver Disease;Cystic Fibrosis in Children;Adherence, Medication;Cystic Fibrosis Gastrointestinal Disease | Drug: Kaftrio | Royal College of Surgeons, Ireland | Imperial College London;University College Dublin;University of Limerick;Cystic Fibrosis Registry of Ireland;Erasmus Medical Center;Medizinische Hochschule Brandenburg Theodor Fontane;Queen's University, Belfast;Teagasc;The Hospital for Sick Children;St. James's Hospital, Ireland;Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Recruiting | 6 Years | N/A | All | 237 | Phase 4 | Ireland;United Kingdom |
| 11 | EUCTR2021-000694-85-BE (EUCTR) | 21/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del 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-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor 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 Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 12 | EUCTR2020-004885-21-BE (EUCTR) | 15/09/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in 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] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 | 143 | Phase 3 | Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands | |||
| 13 | EUCTR2021-005914-33-SE (EUCTR) | 16/05/2022 | Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del | A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del | 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: Kaftrio Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/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 Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden | |||
| 14 | EUCTR2020-004885-21-NL (EUCTR) | 22/09/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in 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] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / 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 | NA | Female: yes Male: yes | 143 | Phase 3 | Czechia;Spain;Belgium;Netherlands |