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

Trial ID or NCT#

NCT01614457

Status

recruiting iconRECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 6 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

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Contact

Angela Leung
6507235193