This study is in progress, not accepting new patients

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

a study on Cystic Fibrosis Fibrosis

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

Description

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.

Official Title

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis

Keywords

Cystic Fibrosis, Fibrosis, VX-121/TEZ/D-IVA

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California Davis Medical Center
    Sacramento California 95817 United States
  • University of California San Francisco, Lung Transplant Program
    San Francisco California 94143 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States
  • Kaiser Permanente
    Oakland California 94611 United States
  • Miller Children's Hospital / Long Beach Memorial
    Long Beach California 90806 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT05444257
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 822 people participating
Last Updated