Overview

Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Status:
Active, not recruiting

Trial end date:
2024-04-01

Target enrollment:
0

Participant gender:
All

Summary

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

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 (VX18-445-106 Part B, NCT03691779), 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