Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities.

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Detailed Description

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The aims of our study are:

1. to describe the treated population at initiation of treatment,
2. to evaluate clinical parameters during the year before Ivacaftor was started, at initiation of treatment and during at least one year of treatment, until June 2014.
3. to evaluate the tolerance and safety of this treatment.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ivacaftor 1

patients with CF who are homozygous or heterozygous for the G551D mutation and treated with Ivacaftor

CF patients with a G551D mutation and treated with Ivacaftor

Intervention Type DRUG

Interventions

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CF patients with a G551D mutation and treated with Ivacaftor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation
* Treated with Ivacaftor
* First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials)