299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
Showing 1 to 10 of 91 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 | 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 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) A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and ... | 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: 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 Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination INN or Proposed INN: Tezacaftor Ot ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Canada;Belgium;Spain;Australia | ||
| 2 | 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 A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Th ... | 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: 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 Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA IN ... | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 3 | EUCTR2019-001827-11-IE (EUCTR) | 28/02/2020 | 20/12/2019 | Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fi ... | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combinati ... | 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-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: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Product Name: IVACAFTOR Product Name: VX-445/ TEZ / IVAFDC Product Code: VX-445/ TEZ / IVA INN or Proposed INN: IVACAFTOR Other ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | ||
| 4 | EUCTR2019-000833-37-DE (EUCTR) | 23/01/2020 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Thera ... | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Trikafta Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed I ... | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;United Kingd ... | ||
| 5 | EUCTR2019-000833-37-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Thera ... | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed I ... | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingd ... | ||
| 6 | EUCTR2018-002835-76-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508 ... | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed I ... | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingd ... | ||
| 7 | 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 A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Th ... | 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: 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: S ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Belgium;Australia;Germany;United Kingdom | ||
| 8 | EUCTR2018-004652-38-IE (EUCTR) | 15/01/2020 | 17/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subject ... | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, famil ... | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAF ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerlan ... | ||
| 9 | EUCTR2019-000833-37-ES (EUCTR) | 19/11/2019 | 09/08/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Thera ... | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed I ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United ... | ||
| 10 | EUCTR2018-004652-38-GB (EUCTR) | 06/11/2019 | 19/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subject ... | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, famil ... | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAF ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | Canada;United States;Ireland;Denmark;Poland;United Kingdom;Israel;Australia;Switzerland;Germany;Spain Canada;United States;Ireland;Denmark;Poland;United Kingdom;Israel;Australia;Switzerland;Germany;Spai ... |