100-mg ELX (VX-445) / 50-mg TEZ / 75-mg IVA FDC ( DrugBank: - )

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1 disease

ID	Disease name (Link within this page)	Number of trials
299	Cystic fibrosis	1

299. Cystic fibrosis

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Clinical trials : 1,695 /  Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 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	EUCTR2018-000185-11-DE (EUCTR)		03/07/2018	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 Homozygous or Heterozygous for the 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: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Trikafta Product Name: 100-mg ELX (VX-445) / 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 Trade Name: Kalydeco 150 mg film-c	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	460	Phase 3	United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden