Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Liver transplant performed using organ donated after circulatory death (DCD)
IC confirmed by endoscopic retrograde cholangiography at least 12 months prior to study enrolment.
If previously treated with biliary dilation or stenting, subjects must be stent-free at time of study enrolment.
IC sub-typed as multifocal progressive or confluence dominant.
Alkaline phosphatase >2x upper limit of normal (>210 IU/ml) within 3 months of study enrolment
Exclusion Criteria:
Presence of endoscopically placed plastic or metal biliary stents or percutaneous biliary drains.
Hepatic artery stenosis or thrombosis that has not been addressed with surgical revision, angioplasty, stenting. If intervention was performed, documentation of post-intervention normalization of hepatic artery resistive indices to >0.55 for >3 months prior to study enrolment.
Diffuse necrosis or minor form sub-types of post-transplant cholangiopathy.
Use of PPAR agonist (e.g fenofibrate, elafibranor, seladelpar) or ursodeoxycholic acid therapy as these will pharmacologically alter BA profiles during the study period.
Study subject is not being considered for re-transplantation.
Liver transplant performed for primary sclerosing cholangitis or primary biliary cholangitis, the recurrence of which will alter BA profiles.
Chronic ductopenic rejection.
Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study physicians, may interfere with patient treatment, safety, assessment, or compliance with the study protocol.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/2/2025. Questions regarding updates should be directed to the study team contact.