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 San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Jonathan Singer
Headshot of Jonathan Singer
Jonathan Singer

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, 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

  • UCSF, Lung Transplant Program
    San Francisco California 94143 United States
  • Kaiser Permanente
    Oakland California 94611 United States

Lead Scientist at UCSF

  • Jonathan Singer
    Dr. Jonathan Singer is a Professor of Medicine in the Division of Pulmonary, Critical Care, Allergy and Sleep Medicine. He specializes in the care of adults with advanced lung disease and lung transplant recipients.

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