TEZACAFTOR ( DrugBank: Tezacaftor )

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	189

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

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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	EUCTR2021-000713-17-HU (EUCTR)	24/01/2023	15/11/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Thera ...	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: teza ...	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland; ...
2	EUCTR2021-000713-17-GR (EUCTR)	04/01/2023	18/10/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Thera ...	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: teza ...	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland; ...
3	EUCTR2021-005930-40-SE (EUCTR)	20/12/2022	29/09/2022	Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis Subjects 1 Through 11 Years of Age	A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deuti ...	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: VX-1 ...	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	65	Phase 3	France;United States;Australia;Germany;Netherlands;United Kingdom;Switzerland;Sweden
4	NCT05331183 (ClinicalTrials.gov)	November 23, 2022	8/4/2022	Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Su ...	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
5	NCT05535959 (ClinicalTrials.gov)	September 15, 2022	7/9/2022	A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezaca ...	A Phase 1, Randomized, Open-label, Crossover Study to Evaluate the Relative Bioavailability of a Fix ...	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	55 Years	All	16	Phase 1	United States
6	NCT05599230 (ClinicalTrials.gov)	September 1, 2022	21/10/2022	Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic ...	Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic ...	Cystic Fibrosis	Drug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor50 MG, 2 tablets each morning + Ivacaftor 150 ...	CHC Montlegia	NULL	Active, not recruiting	12 Years	N/A	All	20		Belgium
7	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 ...	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;Sy ...	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 ...
8	NCT05437120 (ClinicalTrials.gov)	July 22, 2022	23/6/2022	Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moder ...	A Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of VX-121/Tez ...	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA	Vertex Pharmaceuticals Incorporated	NULL	Recruiting	18 Years	70 Years	All	24	Phase 1	United States
9	NCT05422222 (ClinicalTrials.gov)	June 21, 2022	13/6/2022	Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Year ...	A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deuti ...	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA	Vertex Pharmaceuticals Incorporated	NULL	Recruiting	1 Year	11 Years	All	210	Phase 3	United States;Switzerland
10	NCT05274269 (ClinicalTrials.gov)	May 9, 2022	1/3/2022	Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibros ...	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 ...

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