A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
- Registration Number
- NCT05444257
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 822
- Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
- Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A
Key
- History of drug intolerance in a parent study
- Pregnant or breast-feeding females at the time of enrollment in Part A
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VX-121/TEZ/D-IVA VX-121/TEZ/D-IVA Part A: Participants will receive VX-121/TEZ/D-IVA once daily for 96 weeks. Part B: Participants will receive VX-121/TEZ/D-IVA once daily for an additional 48 weeks.
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline up to Week 148
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in Sweat Chloride (SwCl) From Baseline up to Week 144 Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline up to Week 144 Number of Pulmonary Exacerbations (PEx) From Baseline up to Week 144
Trial Locations
- Locations (195)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Miller Children's Hospital / Long Beach Memorial
🇺🇸Long Beach, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Oakland, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of California San Francisco, Lung Transplant Program
🇺🇸San Francisco, California, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Scroll for more (185 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States