299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 | ||
| 3 | NCT04537793 (ClinicalTrials.gov) | November 19, 2020 | 28/8/2020 | 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 | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 93 | Phase 3 | United States;Australia;Canada;Germany;United Kingdom |
| 4 | EUCTR2018-001695-38-GB (EUCTR) | 09/10/2019 | 19/08/2019 | Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis 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: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ 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: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | ||
| 5 | NCT04038710 (ClinicalTrials.gov) | September 5, 2019 | 26/7/2019 | Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease. | An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy. | Cystic Fibrosis | Drug: Triple combination therapy | National Jewish Health | NULL | Completed | 12 Years | N/A | All | 8 | United States | |
| 6 | NCT03691779 (ClinicalTrials.gov) | October 2, 2018 | 28/9/2018 | Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 66 | Phase 3 | United States;Australia;Ireland;United Kingdom |
| 7 | NCT03633526 (ClinicalTrials.gov) | August 3, 2018 | 27/7/2018 | Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 6 Years | 11 Years | All | 18 | Phase 3 | United States |
| 8 | EUCTR2020-002239-31-DE (EUCTR) | 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 | NA | Female: yes Male: yes | 70 | Phase 3 | United States;Canada;Australia;Germany;United Kingdom | |||
| 9 | EUCTR2018-001695-38-IE (EUCTR) | 28/08/2019 | Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis 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: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ 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: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom |