A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Parrimon, Yozandra

    Trial Phone: 321.841.5278 ; 321.841.1361

  • IRB No: 17.056.05

    Protocol Abbrev: VX16-661-114

    Principal Investigator: Mark R. Weatherly, MD

    Sub Investigators: Sabogal, Carlos MD; Garcia, Daniel MD; Faverio, Luis MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: VX16-661-114

    Treatment: Medication

    Applicable Disease Sites: Cystic Fibrosis

    Therapies Involved: Tezacaftor & Ivacaftor

    ClinicalTrials.gov ID: NCT03150719

  • Objective

    To evaluate the respiratory safety of TEZ/IVA in subjects with CF homozygous for F508del and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment

  • Key Eligibility

    Subjects aged 12 years and older with CF who are homozygous for F508del and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment.