Not Yet RecruitingPhase 2

Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC).

10 participantsStarted 2026-05

Plain-language summary

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).

Who can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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
✓. No recent hospitalization within 2 weeks before enrollment to ensure clinical stability

Exclusion criteria

✕. 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
✕. Known hypersensitivity or contraindication to seladelpar or its excipients.
✕. Severe concomitant illness (renal, cardiac, or other systemic condition) that, in the investigator's judgment, would interfere with study participation or interpretation of results.
✕. ALT \> 150 IU/L.
✕. AST \> 150 IU/L.

What they're measuring

serum alkaline phosphatase (ALP)

Timeframe: 26 weeks

Trial details

NCT IDNCT07305363

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Medical Director of Liver Transplantation, MD

858-246-2181 v1ajmera@health.ucsd.edu

View on ClinicalTrials.gov More Liver Transplant; Complications trials