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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).

NCT ID: NCT07305363

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Liver Transplant; Complications Ischemic Cholangiopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Seladelpar

Seladelpar 10 mg orally once daily for 52 weeks

Seladelpar

Intervention Type DRUG

Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist

Interventions

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Seladelpar

Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Veeral Ajmera

Associate Professor Of Clinical, Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Medical Director of Liver Transplantation, MD

Role: CONTACT

Phone: 858-246-2181

Email: [email protected]

Other Identifiers

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Clinical Protocol #:NRC-2023-1

Identifier Type: -

Identifier Source: org_study_id