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
Showing 1 to 10 of 54 diseases
| 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 Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor(ELX/TEZ/IVA) Long-term Safety and Efficacy in Sub ... | 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 A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Iv ... | 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 Study to Evaluate Elexacaftor/Tezacaftor/IvacaftorLong-term Safety and Efficacy in Subjects Without ... | 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 A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Iva ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Trade Name: Kaftrio Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Prop ... | 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 Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium ... | ||
| 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 Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor(ELX/TEZ/IVA) in Cystic Fibrosi ... | 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 A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of E ... | 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 Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;Norway;Poland;Portugal;Spain ... |
| 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;P ... | ||
| 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 United States;Portugal;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia; ... | ||
| 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Clas ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 Portugal;United States;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom; ... | ||
| 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 Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and O ... | 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 A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Iv ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: 80mg ELX / 40mg TEZ / 60mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor O ... | 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;P ... | ||
| 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;P ... | ||
| 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | 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 Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia; ... |