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Study details
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Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

Vertex Pharmaceuticals Incorporated
NCT IDNCT05422222ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

210

Study length

about 8 years

Ages

1–11

Locations

19 sites in CA, CO, GA +12

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take VX-121/TEZ/D-IVA
PhasePhase 3
Primary goalPart A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low5%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

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

Body systems

Respiratory