Overview
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2030-10-01
2030-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Criteria
Key Inclusion Criteria:- Participants who have completed study drug treatment in the parent study
(VX21-121-105; NCT Number: NCT05422222)
Key Exclusion Criteria:
- Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe
hepatic impairment that might pose an additional risk in administering study drug
- History of solid organ, hematological transplantation, or cancer
- History of drug intolerance in the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.