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Drug & research development » Clinical trials » NCT01614457

Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation

Clinical Trials gov number: NCT01614457

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Purpose: To evaluate the efficacy and safety of ivacaftor in CF patients who have the R117H-CFTR mutation.

Phase: 3

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation Therapeutics

  • Male or female with confirmed diagnosis of CF
  • ≥1 allele of the R117H CFTR mutation
  • Percent predicted forced expiratory volume in 1 second (FEV1) 40–90% (for subjects aged ≥12 years) or 40–105% (for subjects aged 6–11 years) predicted normal for age, sex, and height
  • Minimum weight of 15kg at screening
  • Females of childbearing potential must not be pregnant
  • Willing to comply with contraception requirements

Intervention
Ivacaftor

Geographical Location
United Kingdom, United States

Number of Participants
51-100 (≥6 years)

Primary Endpoint

Absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) through Week 24

Secondary Endpoint

Time to first pulmonary exacerbation (Day 0-15, Day 57-112, Day 113-168)

At Week 24

  • Change from baseline (BL) in body mass index
  • Change from BL in sweat chloride
  • Change from BL in Cystic Fibrosis Questionnaire-Revised Respiratory Domain Score
  • Number of subjects with adverse events and serious adverse events  from baseline to 3-4 weeks after last dose at Week 24

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  • Experimental:

     Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.

  • Placebo Comparator: Placebo

     Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.

View Trial Results