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Gut Imaging for Function & Transit in CF - GIFT-CF 3

NCT04618185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2024-05-23

No results posted yet for this study

Summary

An observational study of patients with cystic fibrosis (CF) starting treatment with Kaftrio (Elexacaftor / Tezacaftor / Ivacaftor) as part of routine clinical care, following EMA licensing (approved end of Aug 2020).

* Patients with CF who are p.Phe508del homozygotes will already be receiving the less effective CFTR modulator drug Symkevi (Tezacaftor / Ivacaftor) and will switch to KaftrioTM.
* Patients who are who are compound heterozygotes with at least 1 copy of p.Phe508del currently have access to no effective CFTR modulator and will be starting a CFTR modulator (Kaftrio) for the first time.

Participants attend a study visit before Kaftrio treatment commences, followed by visits at 12 and 24 weeks after starting treatment. At each visit they will be scanned before and after standardised meals in the morning and mid-day (11 scans in total over 6 hours). No intravenous contrast or bowel preparation will be used. Participants will complete questionnaires on gastrointestinal symptoms as well as providing stool and sputum samples for assessment of microbiome and stool for inflammatory mediators and pancreatic function (elastase).

\*\*Following an extension, participants had a further visit at 76 weeks post starting Kaftrio, updated in detailed description\*\*

Conditions

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

MRI to study gut function and transit without the risk of exposure to ionising radiation.

Sponsors & Collaborators

Principal Investigators

  • Alan Smyth · University of Nottingham

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2023-06-28
Completion
2023-06-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT04618185 on ClinicalTrials.gov