NCT05253859Completed
CFTR Modulators and Gastrointestinal Complications
Source: ClinicalTrials.gov · Last updated 3 Jul 2024
Brief summary (registry, in English)
To elucidate the similarities and distinctions in non-pulmonary manifestations of cystic fibrosis (CF) including distal intestinal obstruction syndrome (DIOS) incidence and pancreatic enzyme replacement therapy (PERT) use between US and UK CF populations in a parallel study using data from the UK and US CF registries. To assess how CFTR modulators impacted upon recorded PERT use and incidence of DIOS.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 47023 (actual)
- First submitted
- 14 Feb 2022
- Start date
- 1 Oct 2021
- Primary completion date
- 10 Feb 2024
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Diseases
- Cystic fibrosis
- NCT number
- NCT05253859
What you commit to
- Study type: Observational
- Participants enrolled: 47023
- From 1 Oct 2021 to the primary completion date, 10 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Patients whose CFTR modulator status is unknown or only have one year of CFTR data recorded on the registry will be excluded from the analysis of the effects of CFTR modulators. This is to account for the fact that DIOS data is annualised on the registries, therefore there is no certainty at what time of year DIOS was diagnosed in relation to commencing CFTR modulator therapy.
Who the study is looking for
- All patients with CF of any genotype on the UK and US cystic fibrosis registries from the period 2007 - 2018.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.