Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Phase 3
210
about 8 years
1–11
19 sites in CA, CO, GA +12
What this study is about
This trial is testing a treatment called VX-121/TEZ/D-IVA for children with cystic fibrosis who have at least one mutation that responds to triple combination therapy. The goal is to see if this treatment is safe, well-tolerated, and effective in these individuals.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take VX-121/TEZ/D-IVA
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary: Part B: Absolute Change in BMI-for-age Z-score, Part B: Absolute Change in Body Mass Index (BMI), Part B: Absolute Change in Weight, Part B: Absolute Change in Weight-for-age Z-score, Part B: Absolute Change in Weight-for-length, Part B: Absolute Change in Weight-for-length Z-score
Respiratory