Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC).
Starting soon · Phase 2
Conditions studied: Liver Transplant; Complications, Ischemic Cholangiopathy
In brief
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).
Key facts
- Study ID
- NCT07305363
- Run by
- University of California, San Diego
- People needed
- 10
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- Total bilirubin > 5 mg/dL at screening
Full record on ClinicalTrials.gov
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