Overview

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

Status:
Active, not recruiting

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
All

Summary

This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Treatments:

Elexacaftor
Ivacaftor

Criteria

Key Inclusion Criteria:

- Completed study drug treatment in parent study (VX18-445-104); or had study drug
interruption(s) in parent study but completed study visits up to the last scheduled
visit of the Treatment Period in the parent study

Key Exclusion Criteria:

- History of study drug intolerance in parent study

Other protocol defined Inclusion/Exclusion criteria may apply