Health TrialsbyHealthPanel

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

ConditionsPrimary Sclerosing CholangitisLiver Transplant, ComplicationsPSCBiliary Strictures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic

About this trial

This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment

Absence of rPSC at time of study enrollment

At least one of the following additional features that increase risk of rPSC

LT performed for cholangiocarcinoma

Disqualifiers

Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and/or are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.

Presence of ischemic cholangiopathy which can mimic rPSC

LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis

Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC

Trial design

Design model

Single group

Treatments tested in this trial

  • Fenofibrate (drug)

    Drug

    Once daily fenofibrate for 36 months

  • Blood draw for the laboratory assessment

    Diagnostic test

    Serum assessments will be performed every 3 months during the study period

  • MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)

    Diagnostic test

    Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 3 interventions
Group B: Historical controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.

Proportion of recipients transplanted for PSC who develop rPSC during a 36-month fenofibrate treatment period, compared to the rate of rPSC in a untreated cohort. The diagnosis of rPSC will be made based on established diagnostic criteria (see Study Design)

Time frame
36 months

Secondary outcomes

1

To quantify the associations between serum alkaline phosphatase and rPSC development in LT recipients treated with fenofibrate

Quantify the relative risk between serum alkaline phosphatase level (IU/L) and the diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of fenofibrate treatment

Time frame
36 months
2

To quantify the associations between total serum bile acid level and rPSC development in LT recipients treated with fenofibrate

Quantify the relative risk between total serum bile acid level (micromol/liter) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of treatment

Time frame
36 months
3

To quantify the associations between serum bile acid profile and rPSC development in LT recipients treated with fenofibrate

Quantify the relative risk between primary bile acids level (nanonmol/mL), secondary bile acid level (nanonmol/mL), and glycine:taurine conjugate bile acid level (nanonmol/mL) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of fenofibrate treatment

Time frame
36 months
4

To quantify the associations between fibroblast growth factor 19 level and rPSC development in LT recipients treated with fenofibrate

Quantify the relative risk between serum fibroblast growth factor 19 level (picogram/ml) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of treatment

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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