A Phase 3 Open-label Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older Homozygous or Heterozygous for the F508del-CFTR Mutation

Overview

The purpose of this study is to evaluate the long-term safety and tolerability of TEZ/IVA in subjects with cystic fibrosis aged 6 years and older, who are homozygous or heterozygous for F508del mutation.

Description

The purpose of this study is to evaluate the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: cystic fibrosis
  • Age: Between 6 Years - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Male and female subjects with CF aged 6 years and older, who completed Study 113
Part B or Study 115 and are
homozygous for F508del (F/F),
heterozygous for F508del and a second allele with a residual CFTR-function
mutation (F/RF), or
heterozygous for F508del and a second allele that has been shown to be
responsive to TEZ/IVA
Exclusion Criteria
History of any comorbidity that, in the opinion of the investigator, might confound the results
of the study or pose an additional risk in administering study drug to the subject
Pregnant and nursing females
Sexually active subjects of reproductive potential who are not willing to follow the
contraception requirements
History of drug intolerance in the parent study that would pose an additional risk to the
ubject in the opinion of the investigator, and which should be discussed with the Vertex
medical monitor
History of poor compliance with study drug and/or procedures in a previous study as deemed
by the investigator
Ongoing participation in another study with investigational drug


Additional Information:
Participants will not be paid for their participation.

Updated on 30 Nov 2022 . Study ID: TX9368

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