Status:
RECRUITING
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combina...
Eligibility Criteria
Inclusion
- Key
- Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene
- Key
Exclusion
- History of solid organ, hematological transplantation, or cancer
- Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05422222
Start Date
June 21 2022
End Date
June 30 2030
Last Update
November 6 2025
Active Locations (38)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
Stanford University Clinical and Translational Research Unit
Palo Alto, California, United States, 94304
3
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
4
The Emory Clinic / Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322