Liver Transplant; ComplicationsPhase 2SELICNCT07305363
Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC).
A Phase 2 study testing Seladelpar in people with Liver Transplant; Complications and Ischemic Cholangiopathy, run by University of California, San Diego.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Liver Transplant; Complications, Ischemic Cholangiopathy
- What is being tested?
- Seladelpar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- ALT > 150 IU/L.
- AST > 150 IU/L.
- Total bilirubin > 5 mg/dL at screening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The SELIC Trial Seladelpar for the Treatment of Ischemic Cholangiopathy: An Open-Label, Single-Arm, Investigator-Initiated Study
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).
Read the detailed 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.
- Being tested
- Seladelpar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeladelparDrug
Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist
| Study group | Role | What they receive |
|---|---|---|
| Seladelpar | Experimental | Seladelpar 10 mg orally once daily for 52 weeks Receives: Drug: Seladelpar |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum alkaline phosphatase (ALP)
Determine the effect of seladelpar on serum alkaline phosphatase (ALP) from baseline to week 26
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veeral Ajmera, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305363
- Sponsor's protocol ID
- Clinical Protocol#SELIC-2025-1
- Acronym
- SELIC
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SELIC Trial Seladelpar for the Treatment of Ischemic Cholangiopathy: An Open-Label, Single-Arm, Investigator-Initiated Study
- ClinicalTrials.gov ID
- NCT07305363
- Acronym / sponsor ID
- SELIC / Clinical Protocol#SELIC-2025-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seladelpar | Experimental | Drug: SeladelparSeladelpar 10 mg orally once daily for 52 weeks |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeladelparSeladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist | Drug | Seladelpar |
Primary outcome
serum alkaline phosphatase (ALP)
Time frame: 26 weeks
Determine the effect of seladelpar on serum alkaline phosphatase (ALP) from baseline to week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seladelpar in people with Liver Transplant; Complications and Ischemic Cholangiopathy, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director of Liver Transplantation, MD (858-246-2181, v1ajmera@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum alkaline phosphatase (ALP) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.