Status:
COMPLETED
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Effi-Stat
Societe Francaise de la Mucoviscidose
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
The purpose of the study is to examine the real-life safety and effectiveness of the novel combination ivacaftor+lumacaftor in eligible patients with cystic fibrosis (CF). All patients with CF were el...
Detailed Description
Each patient is followed one year with visits at months 1, 3, 6 and 12. At each visit, the following data are recorded: * Treatment discontinuation or not. If the treatment was discontinued, reasons...
Eligibility Criteria
Inclusion
- Patient aged 12 years or older.
- Patient with Cystic Fibrosis with presence of two mutations DF508 in the CFTR gene
- Patient treated with ivacaftor+lumacaftor (Orkambi)
Exclusion
- Refusal to participate in the study
- Start of Orkambi as part of a clinical trial
Key Trial Info
Start Date :
January 22 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
852 Patients enrolled
Trial Details
Trial ID
NCT03475381
Start Date
January 22 2016
End Date
December 31 2018
Last Update
December 1 2025
Active Locations (1)
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1
Adult CF center, Service de Pneumologie, Cochin Hospital
Paris, Paris, France, 75006