A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
J
James Chmiel
Primary Investigator
C
Cynthia Brown, MD
Primary Investigator
Administratively Closed
12 years or above
All
Phase
3
850 participants needed
2 Locations
Brief description of study
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cystic Fibrosis
-
Age: 12 years or above
-
Gender: All
Key Inclusion Criteria:
- Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) andVX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study butdid not permanently discontinue study drug, and completed study visits up to the lastheduled visit of the Treatment Period in the parent study
Key Exclusion Criteria:
- History of drug intolerance in a parent study
- Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply.
Updated on
13 Dec 2024.
Study ID: PULM-VERTEX-VX20-121-104, 16396, 15584
