Overview
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-06-01
2022-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in subjects with cystic fibrosis (CF) who are homozygous for F508del.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vertex Pharmaceuticals IncorporatedTreatments:
Elexacaftor
Ivacaftor
Criteria
Key Inclusion Criteria:- Completed study drug treatment in parent study (VX18-445-109); 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