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Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)

NCT03475381 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 852

Last updated 2025-12-01

No results posted yet for this study

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 eligible if they were 12 years and older, started ivacaftor+lumacaftor outside of a clinical trial between December 15th 2017 and December 15th 2018 in an accredited CF center in France. Patient followed-up is based on standardized recommendation of the French Cystic Fibrosis Society. Each patient is followed 1 year.

Conditions

Interventions

DRUG

Ivacaftor+lumacaftor

1 year follow-up after initiation of ivacaftor+lumacaftor

Sponsors & Collaborators

  • Effi-Stat

    collaborator OTHER

  • Societe Francaise de la Mucoviscidose

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre-Regis BURGEL, MD, PhD · Hôpitaux Universitaire Paris Centre, AP-HP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-22
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT03475381 on ClinicalTrials.gov