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

Health Conditions
  • Cystic Fibrosis
Completed
Recruitment Status
NCT01614457
Primary Trial ID Number
Summary
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
Primary Outcome Measures
  • Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24; Baseline, Week 24
Secondary Outcome Measures
  • Change From Baseline in Body Mass Index (BMI) at Week 24; Baseline, Week 24; Change From Baseline in Sweat Chloride Through Week 24; Baseline, Week 24; Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24; Baseline, Week 24; Time to First Pulmonary Exacerbation; Day 0 to 15, Day 16 to 56, Day 57 to 112, Day 113 to 168; Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs); Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])
Research Question
  • The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; United Kingdom
Participant Sex
Both
Participant Age Range
6 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Male or female with confirmed diagnosis of CF
  • - Must have at least 1 allele of the R117H CFTR mutation
  • - Percent predicted forced expiratory volume in 1 second (FEV1) 40 percent (%) to 90%
  • (for subjects aged 12 years or older) or 40% to 105% (for subjects aged 6 to 11
  • years) predicted normal for age, sex, and height
  • - 6 years of age or older
  • - Minimum weight of 15 kilogram (kg) at screening
  • - Females of childbearing potential must not be pregnant
  • - Willing to comply with contraception requirements
  • Exclusion Criteria:
  • - CFTR gene mutation leading to CFTR channel with gating defect (that is, any 1 of the
  • following mutations: G551D, G178R, G551S, S549N, S549R, G970R, G1244E, S1251N,
  • S1255P, or G1349D)
  • - History of any illness or condition that might confound the results of the study or
  • pose an additional risk in administering ivacaftor to the subject
  • - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
  • therapy (including antibiotics) for pulmonary disease within 4 weeks before the first
  • dose of study drug
  • - Abnormal liver function, at screening, defined as greater than or equal to (>=) 3
  • time upper limit of normal (ULN), of any 3 or more of the following: serum aspartate
  • transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase
  • (GGT), serum alkaline phosphatase (ALP), total bilirubin
  • - Colonization with organisms associated with a more rapid decline in pulmonary status
  • (for example, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium
  • abscessus) at screening
  • - History of solid organ or hematological transplantation
  • - History of alcohol, medication or illicit drug abuse within 1 year before the first
  • dose of study drug
  • - Ongoing participation in another therapeutic clinical study or prior participation in
  • an investigational drug study within 30 days before screening
  • - Any "non-CF-related" illness within 2 weeks before Day 1 (first dose of study drug).
  • "Illness" was defined as an acute (serious or non-serious) condition (for example,
  • gastroenteritis)
  • - Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Male or female with confirmed diagnosis of CF
  • - Must have at least 1 allele of the R117H CFTR mutation
  • - Percent predicted forced expiratory volume in 1 second (FEV1) 40 percent (%) to 90%
  • (for subjects aged 12 years or older) or 40% to 105% (for subjects aged 6 to 11
  • years) predicted normal for age, sex, and height
  • - 6 years of age or older
  • - Minimum weight of 15 kilogram (kg) at screening
  • - Females of childbearing potential must not be pregnant
  • - Willing to comply with contraception requirements
  • Exclusion Criteria:
  • - CFTR gene mutation leading to CFTR channel with gating defect (that is, any 1 of the
  • following mutations: G551D, G178R, G551S, S549N, S549R, G970R, G1244E, S1251N,
  • S1255P, or G1349D)
  • - History of any illness or condition that might confound the results of the study or
  • pose an additional risk in administering ivacaftor to the subject
  • - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
  • therapy (including antibiotics) for pulmonary disease within 4 weeks before the first
  • dose of study drug
  • - Abnormal liver function, at screening, defined as greater than or equal to (>=) 3
  • time upper limit of normal (ULN), of any 3 or more of the following: serum aspartate
  • transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase
  • (GGT), serum alkaline phosphatase (ALP), total bilirubin
  • - Colonization with organisms associated with a more rapid decline in pulmonary status
  • (for example, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium
  • abscessus) at screening
  • - History of solid organ or hematological transplantation
  • - History of alcohol, medication or illicit drug abuse within 1 year before the first
  • dose of study drug
  • - Ongoing participation in another therapeutic clinical study or prior participation in
  • an investigational drug study within 30 days before screening
  • - Any "non-CF-related" illness within 2 weeks before Day 1 (first dose of study drug).
  • "Illness" was defined as an acute (serious or non-serious) condition (for example,
  • gastroenteritis)
  • - Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
Interventions
Drug; Ivacaftor; Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.; [Ivacaftor]; Drug; Placebo; Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.; [Placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
KONDUCT
Scientific 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
Secondary Trial Identifying Number
Sorry, this information is not available
Website
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Study Funded By
Vertex Pharmaceuticals Incorporated
Funder Type
Sorry, this information is not available
Study Sponsored By
Vertex Pharmaceuticals Incorporated
Study Also Sponsored By
Cystic Fibrosis Foundation Therapeutics
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

05 Jun 2012

Last Updated

31 Jan 2015

Date Record Refreshed on UKCTG

31 Jul 2015