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Clinical trial

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

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Last updated:8th Aug 2019
Identifier: NCT04043806

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

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