Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)
KONDUCT
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
1 other identifier
interventional
70
2 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2012
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
February 12, 2015
CompletedFebruary 12, 2015
January 1, 2015
1.3 years
June 5, 2012
January 31, 2015
January 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years.
Baseline, Week 24
Secondary Outcomes (5)
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])
Study Arms (2)
Ivacaftor
EXPERIMENTALIvacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
Placebo
PLACEBO COMPARATORPlacebo matched to Ivacaftor tablet orally twice daily for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vertex Pharmaceuticals Incorporatedlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (31)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
Valhalla, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Morgantown, West Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Belfast, United Kingdom
Unknown Facility
Edinburgh, United Kingdom
Related Publications (1)
Moss RB, Flume PA, Elborn JS, Cooke J, Rowe SM, McColley SA, Rubenstein RC, Higgins M; VX11-770-110 (KONDUCT) Study Group. Efficacy and safety of ivacaftor in patients with cystic fibrosis who have an Arg117His-CFTR mutation: a double-blind, randomised controlled trial. Lancet Respir Med. 2015 Jul;3(7):524-33. doi: 10.1016/S2213-2600(15)00201-5. Epub 2015 Jun 9.
PMID: 26070913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Moss, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 8, 2012
Study Start
July 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 12, 2015
Results First Posted
February 12, 2015
Record last verified: 2015-01