Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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 setting, after the drug has been approved by the Health authorities.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Vaincre la Mucoviscidose
• Treatments: Ivacaftor

Criteria

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)

Exclusion Criteria:

• CF patients younger than 6 years old

• CF patients who have received lung transplantation

• CF patients without a G551D mutation.