Elexacaftor/tezacaftor/ivacaftor ( DrugBank: Ivacaftor, Tezacaftor, Elexacaftor )
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 | 54 |
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 | NCT05331183 (ClinicalTrials.gov) | November 23, 2022 | 8/4/2022 | Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 6 Years | N/A | All | 270 | Phase 3 | Belgium;France;Germany;Netherlands;Spain;Switzerland |
| 2 | 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 | ||
| 3 | NCT05274269 (ClinicalTrials.gov) | May 9, 2022 | 1/3/2022 | Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA) | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 307 | Phase 3 | Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland |
| 4 | EUCTR2021-000694-85-HU (EUCTR) | 03/05/2022 | 05/04/2022 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 5 | EUCTR2021-000712-31-HU (EUCTR) | 02/05/2022 | 05/04/2022 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | ||
| 6 | 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 | ||
| 7 | EUCTR2020-002239-31-DE (EUCTR) | 18/03/2022 | 20/12/2021 | Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and Older | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older | 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: 80mg ELX / 40mg TEZ / 60mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: IVACAFTOR 59.5mg Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 100g ELX / 50mg TEZ / 75mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Trade Name: Kalydeco Product Name: IVACAFTOR 75mg Product Code: VX-77 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Canada;Australia;Germany;United Kingdom | ||
| 8 | EUCTR2021-000694-85-DK (EUCTR) | 17/03/2022 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 9 | EUCTR2021-000694-85-AT (EUCTR) | 16/02/2022 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 10 | EUCTR2021-000712-31-SE (EUCTR) | 18/01/2022 | 22/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | ||
| 11 | NCT05153317 (ClinicalTrials.gov) | January 17, 2022 | 29/11/2021 | Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 2 Years | N/A | All | 70 | Phase 3 | United States;Australia;Canada;Germany;United Kingdom |
| 12 | 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 | ||
| 13 | NCT05111145 (ClinicalTrials.gov) | January 14, 2022 | 27/10/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 86 | Phase 3 | Australia;Belgium;Canada;Czechia;Spain |
| 14 | EUCTR2021-000712-31-DE (EUCTR) | 12/01/2022 | 23/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | EUCTR2021-000712-31-CZ (EUCTR) | 08/12/2021 | 23/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Hungary;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | ||
| 19 | EUCTR2021-000694-85-GR (EUCTR) | 07/12/2021 | 19/10/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2021-000694-85-NO (EUCTR) | 03/12/2021 | 20/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | EUCTR2021-000694-85-SE (EUCTR) | 10/11/2021 | 22/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 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;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 24 | EUCTR2020-002251-38-DE (EUCTR) | 28/09/2021 | 20/07/2021 | Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age | 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: 80mg ELX / 40mg TEZ / 60mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: IVACAFTOR INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: IVACAFTOR 59,5mg Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100g ELX / 50mg TEZ / 75mg IVA INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: IVACAFTOR 75mg INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Germany;United Kingdom | ||
| 25 | EUCTR2021-001628-16-ES (EUCTR) | 30/07/2021 | 20/07/2021 | A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation 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: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: 150mg 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 | 100 | Phase 3 | Canada;Belgium;Spain;Australia | ||
| 26 | 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 | ||
| 27 | EUCTR2020-001404-42-DK (EUCTR) | 09/02/2021 | 05/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Australia;Denmark;Israel;Germany;Netherlands;United Kingdom;Switzerland | ||
| 28 | NCT04545515 (ClinicalTrials.gov) | January 11, 2021 | 3/9/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes | A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 120 | Phase 3 | Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom |
| 29 | EUCTR2020-001404-42-NL (EUCTR) | 06/01/2021 | 07/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland | ||
| 30 | EUCTR2020-003170-44-IT (EUCTR) | 14/12/2020 | 15/06/2021 | NA | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic FibrosisSubjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance 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] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) Product Code: [NA] INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: [VX-770] INN or Proposed INN: IVACAFTOR | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 31 | EUCTR2020-003170-44-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance 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] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 32 | NCT04509050 (ClinicalTrials.gov) | November 18, 2020 | 6/8/2020 | Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children | A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study) | Cystic Fibrosis | Drug: Ivacaftor or elexacaftor/tezacaftor/ivacaftor | Sonya Heltshe | Cystic Fibrosis Foundation;University of Washington;University of Alabama at Birmingham | Active, not recruiting | N/A | 5 Years | All | 210 | United States | |
| 33 | EUCTR2019-003554-86-FR (EUCTR) | 29/10/2020 | 02/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 34 | EUCTR2020-001404-42-GB (EUCTR) | 12/10/2020 | 25/08/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Open-label Study of ELX/TEZ/IVA in subjects 6 years & older | 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | Israel;Netherlands;Germany;Switzerland;United Kingdom;France;Canada;Spain;Denmark;Australia | ||
| 35 | EUCTR2019-003554-86-DK (EUCTR) | 19/08/2020 | 27/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | Germany;United Kingdom;Switzerland;France;Canada;Spain;Australia;Denmark;Israel;Netherlands | ||
| 36 | EUCTR2019-003554-86-DE (EUCTR) | 14/08/2020 | 12/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 37 | EUCTR2019-003554-86-NL (EUCTR) | 28/07/2020 | 01/05/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland | ||
| 38 | NCT04362761 (ClinicalTrials.gov) | May 4, 2020 | 22/4/2020 | A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy | A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 172 | Phase 3 | Australia;Belgium;Germany;United Kingdom |
| 39 | EUCTR2019-003554-86-GB (EUCTR) | 01/05/2020 | 01/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Study of ELX/TEZ/IVA in CF subjects 6 Through 11 Years of Age | 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;Switzerland;United Kingdom | ||
| 40 | EUCTR2019-003455-11-DE (EUCTR) | 08/04/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy 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] | Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 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: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: Ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 41 | EUCTR2019-003455-11-GB (EUCTR) | 17/01/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy 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 ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 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: 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 | 158 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Australia;Germany;United Kingdom | ||
| 42 | EUCTR2020-003170-44-FR (EUCTR) | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance 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] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | |||
| 43 | EUCTR2021-001628-16-BE (EUCTR) | 06/08/2021 | A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation 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: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | Canada;Spain;Belgium;Australia | |||
| 44 | 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 | |||
| 45 | EUCTR2021-000694-85-IE (EUCTR) | 29/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | |||
| 46 | EUCTR2020-003170-44-NL (EUCTR) | 09/11/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance 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] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Spain;Belgium;Australia;Netherlands;Italy | |||
| 47 | EUCTR2021-000712-31-IE (EUCTR) | 29/09/2021 | 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 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 Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | |||
| 48 | 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 | |||
| 49 | EUCTR2019-003455-11-BE (EUCTR) | 23/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy 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] | Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 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: 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;United Kingdom;Australia;Germany | |||
| 50 | EUCTR2020-001404-42-DE (EUCTR) | 01/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;France | |||
| 51 | 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 | |||
| 52 | 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 | |||
| 53 | EUCTR2020-001404-42-FR (EUCTR) | 16/11/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | |||
| 54 | EUCTR2020-003170-44-BE (EUCTR) | 16/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance 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] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy |