Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC).
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of California, San Diego
About this trial
A prospective, open-label, single-arm, investigator-initiated study (SELIC) to evaluate the efficacy and safety of seladelpar in adult liver transplant recipients with Ischemic cholangiopathy (IC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult, age ≥ 18 and < 80 years
Diagnosis of ischemic cholangiopathy defined as non-anastomotic biliary strictures confirmed by imaging (ERCP, MRI, percutaneous cholangiogram)
Cholestasis noted by elevated alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT)
Imaging and clinical findings present at least 4 weeks after but within 12 months of liver transplantation
Disqualifiers
Decompensated liver disease, including but not limited to ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding.
Pregnancy or breastfeeding.
Current or recent (within 30 days) use of other investigational agents or fenofibrate.
Current or recent (within 30 days) use of cyclosporine
Trial design
Design model
Single group
Treatments tested in this trial
Seladelpar
DrugSeladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: SeladelparExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
serum alkaline phosphatase (ALP)
Determine the effect of seladelpar on serum alkaline phosphatase (ALP) from baseline to week 26
Time frame
26 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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