Clinical trial
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 480 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
Actual Study Start Date: August 9, 2019
Estimated Primary Completion Date: May 2022
Estimated Study Completion Date: May 2022
Arm:
- Experimental: Open-Label Triple Combination
Category | Value |
---|---|
Date last updated at source | 2019-09-10 |
Study type(s) | Interventional |
Expected enrolment | 480 |
Study start date | 2019-08-09 |
Estimated primary completion date | 2022-05-01 |