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Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation

NCT01614470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-10-29

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

Conditions

Interventions

DRUG

Ivacaftor

150 mg tablet, oral use, administered twice a day (q12h)

DRUG

Placebo

oral use, administered twice a day (q12h)

Sponsors & Collaborators

Principal Investigators

  • Christine De Boeck, MD, PhD · University of Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614470 on ClinicalTrials.gov