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).

University of California San Diego

Status: Not yet enrolling

Conditions: Ischemic Cholangiopathy; Liver Transplant; Complications

Treatments: Drug: Seladelpar

Study type: Observational

Funder types: Other

Identifiers

NCT07305363

Clinical Protocol #:NRC-2023-1

Details and patient eligibility

About

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).

Full description

Ischemic cholangiopathy (IC) is a serious complication after liver transplantation, particularly in recipients of donation after circulatory death grafts, and is associated with cholestasis, biliary strictures, and graft dysfunction. No approved pharmacologic therapies currently exist. Seladelpar, a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist recently approved for primary biliary cholangitis, reduces bile acid synthesis and inflammation and has demonstrated antifibrotic activity, making it a promising candidate for IC. We designed a prospective, open-label, single-arm, investigator-initiated study (SELIC) to evaluate the efficacy and safety of seladelpar in adult liver transplant recipients with IC. Ten patients will receive seladelpar 10 mg orally once daily for 52 weeks. Outcomes will be compared to historical controls identified from the same institution. The primary endpoint is percent change in serum alkaline phosphatase (ALP) from baseline to Week 26. Additional outcomes include ERCP utilization, liver allograft loss, and safety assessed by adverse event and laboratory monitoring and drug discontinuation rates. This pilot study will provide the first prospective data on seladelpar in IC and may establish preliminary evidence for a novel therapeutic approach to reduce cholestasis, improve symptoms, and preserve graft function in this high-risk population.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult, age ≥ 18 and < 80 years
2. Diagnosis of ischemic cholangiopathy defined as non-anastomotic biliary strictures confirmed by imaging (ERCP, MRI, percutaneous cholangiogram)
3. Cholestasis noted by elevated alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT)
4. Imaging and clinical findings present at least 4 weeks after but within 12 months of liver transplantation
5. No recent hospitalization within 2 weeks before enrollment to ensure clinical stability

Exclusion criteria

1. Decompensated liver disease, including but not limited to ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding.
2. Pregnancy or breastfeeding.
3. Current or recent (within 30 days) use of other investigational agents or fenofibrate.
4. Current or recent (within 30 days) use of cyclosporine
5. Known hypersensitivity or contraindication to seladelpar or its excipients.
6. Severe concomitant illness (renal, cardiac, or other systemic condition) that, in the investigator's judgment, would interfere with study participation or interpretation of results.
7. ALT > 150 IU/L.
8. AST > 150 IU/L.
9. Total bilirubin > 5 mg/dL at screening

Trial design

10 participants in 1 patient group

Seladelpar

Description:

Seladelpar 10 mg orally once daily for 52 weeks

Treatment:

Drug: Seladelpar