Status:
UNKNOWN
Gastrointestinal Study at Orkambi Therapy in CF Patients
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Hadassah Medical Organization
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
Ivacaftor caused a significance increase in weight in patients carrying the G551D mutation and the etiology of this has largely remained unknown but may be due to improved function of the gastrointest...
Detailed Description
To examine the entire intestinal mucosa via capsule endoscopy before and 6 months after Orkambi therapy to ascertain if the inflammatory changes in the intestine have improved. A marker of intestinal ...
Eligibility Criteria
Inclusion
- CF patients F508del homozygote
- \>12 years of age
- eligible for Orkambi therapy.
Exclusion
- Patients who the patency capsule does not pass within 48 hrs
- FEV1\<30%
- Pregnancy and breastfeeding women
- Liver function blood tests (AST, ALT, Gamma-GT, ALP) \>3 xULN
- Bilirubin \>2 xULN
- AST or ALT alone \>5 xULN
- Previous lung transplant
Key Trial Info
Start Date :
February 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03859531
Start Date
February 27 2019
End Date
June 30 2020
Last Update
March 4 2019
Active Locations (1)
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1
Stockholm CF Center
Stockholm, Sweden, 14186