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New treatment option for Primary Sclerosing Cholangitis
Official title Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
ClinicalTrials.gov ID: NCT06905054
What this study is testing
What is Fenofibrate (drug)?
Fenofibrate (drug) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior...
- Absence of rPSC at time of study enrollment
- At least one of the following additional features that increase risk of rPSC
- LT performed for cholangiocarcinoma
- Concurrent inflammatory bowel disease
You likely can't join if
- Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and/or are willing to travel to...
- Presence of ischemic cholangiopathy which can mimic rPSC
- LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis...
- Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC
- History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC
- Baseline GFR \<30 ml/min which precludes administration of fenofibrate
See the full eligibility criteria
- Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment
- Absence of rPSC at time of study enrollment
- At least one of the following additional features that increase risk of rPSC
- LT performed for cholangiocarcinoma
- Concurrent inflammatory bowel disease
- Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment
- Any episode of acute cellular rejection in the post-transplant period before the study enrollment
- If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) to expand enrollment to any patient meeting the other inclusion/
- Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and/or are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost...
- Presence of ischemic cholangiopathy which can mimic rPSC
- LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis
- Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC
- History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC
- Baseline GFR \<30 ml/min which precludes administration of fenofibrate
- Previously known intolerance or allergy to fenofibrate
- Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or...
- Female participants that are pregnant or planning to become pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.