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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Elexacaftor; Ivacaftor

Criteria

Inclusion Criteria:

• Currently participating in study VX17-659-105 (NCT03447262)

Exclusion Criteria:

• History of drug intolerance in study VX17-659-105 that would pose an additional risk to the subject in the opinion of the investigator

• Current participation in an investigational drug trial (other than study VX17-659-105)

Other protocol defined Inclusion/Exclusion criteria may apply