Overview

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

Status:
Active, not recruiting
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Ivacaftor
Criteria
Inclusion Criteria:

- Completed study drug treatment in a parent study; or had study drug interruption(s) in
a parent study but completed study visits up to the last scheduled visit of the
Treatment Period in the parent study.

Exclusion Criteria:

- History of drug intolerance in a parent study that would pose an additional risk to
the subject in the opinion of the investigator.

- Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.