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

NCT05444257

Active Not RecruitingPhase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Cystic Fibrosis

Interventions: VX-121/TEZ/D-IVA

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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 (195)
  • Birmingham, Alabama, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Gainesville, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • St. Petersburg, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Lexington, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Portland, Maine, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • + 165 more on CT.gov