A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Trans… (NCT05514119) | Clinical Trial Compass
TerminatedPhase 2
A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
Stopped: Low Enrollment
United States6 participantsStarted 2022-08-17
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT).
* At least one serum alkaline phosphatase level \>2.5x upper limit of normal between post-LT days 21-60 (inclusive).
Exclusion criteria:
* LT performed for primary sclerosing cholangitis or primary biliary cholangitis.
* Untreated hepatic artery compromise (e.g thrombosis, stenosis)
* Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT
* Renal dysfunction defined as baseline glomerular filtration rate \< 30 ml/min.
* Previously known intolerance or allergy to fenofibrate.
* Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment.
* Adults lacking capacity to consent to treatment