Status:
COMPLETED
Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Vaincre la Mucoviscidose
URC-CIC Paris Descartes Necker Cochin
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Brief Summary
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 s...
Detailed Description
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 treatmen...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- CF patients younger than 6 years old
- CF patients who have received lung transplantation
- CF patients without a G551D mutation.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02194881
Start Date
October 1 2014
End Date
May 1 2016
Last Update
November 20 2025
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014