Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
RECOVER is a prospective, multicenter observational study designed to measure the real world
clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy
(Kaftrio) in people with cystic fibrosis over a two year period. Measured outcomes include
measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut
inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of
life and adherence to therapy. The study will examine outcomes in children aged six years and
above over a period of two years. The first phase of the study will commence in 2020,
recruiting children 12 years and older who have started on clinical treatment with Kaftrio.
Phase:
Phase 4
Details
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborators:
Cystic Fibrosis Registry of Ireland Erasmus Medical Center Imperial College London Medizinische Hochschule Brandenburg Theodor Fontane Queen's University, Belfast Teagasc The Hospital for Sick Children University College Dublin University of Limerick