Primary Sclerosing CholangitisPhase 2NCT06905054
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
A Phase 2 study testing Fenofibrate (drug), Blood draw for the laboratory assessment and MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) in people with Primary Sclerosing Cholangitis and Liver Transplant, Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis, Liver Transplant, Complications, PSC
- What is being tested?
- Fenofibrate (drug), Blood draw for the laboratory assessment and MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 1 Jul 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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) inclusion criteria to expand enrollment to any patient meeting the other inclusion/exclusion criteria.
- 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.
Who cannot join
- 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 compliance with the treatment
- Female participants that are pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Han Ly, 480-574-2321, ly.ngochan@mayo.edu
Channa Jayasekera
About this study
Official title: Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
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
Read the detailed description
Primary sclerosing cholangitis (PSC), an immune-mediated, progressive cholestatic disease with no well-established pharmacologic treatment, has an annual incidence of 2.0 per 100,000 and is responsible for 5% of liver transplants (LT) performed in the United States. Recurrent PSC (rPSC) after LT occurs in 8-27% at 5 years and is associated with an over 40% risk of graft loss.
Because PSC patients undergo LT at a younger age than non-PSC patients (median 40-50 years vs 60 years for most other LT indications), rPSC poses significant lifetime morbidity and mortality risk, and development of its early signs of biliary injury, particularly the development cholestasis (elevated alkaline phosphatase), is routinely monitored in the post-transplant setting.
There is no established pharmacologic treatment for rPSC, and the disease is usually characterized by progressive cholestasis to biliary stricturing, cholangitis, allograft fibrosis and ultimately liver failure. Trials of ursodeoxycholic acid and oral vancomycin have been inconclusive. Since most transplants for PSC are performed with Roux-en-Y biliary reconstructions that make re-transplantation challenging, any pharmacologic intervention to reduce the risk of rPSC would represent a breakthrough in disease management.
Cholestasis appears to be a surrogate for PSC disease progression since improvement in alkaline phosphatase levels is associated with slower disease progression, lower rates of cholangiocarcinoma, and improved survival in the pre-transplant setting. Peroxisome proliferator-activated receptor (PPAR) agonists (e.g. fenofibrate, bezafibrate, seladelpar, elafibranor) reduce bile acid-mediated biliary injury by downregulating their synthesis and activity, and promoting choleresis. PPAR agonists have demonstrated efficacy in potently improving cholestasis in PSC pre-transplant, and other cholestatic liver diseases post-transplant.
While fibrates have been shown to improve both biochemical and clinical parameters of PSC in non-transplant patients, whether they can prevent clinically detectable rPSC after transplantation has not been studied. Extrapolating the pre-transplant data to the post-transplant setting, this study hypothesizes that mitigating cholestasis with the use of fibrates in transplant recipients may impede the development of rPSC.
In this study, the primary aim is to assess the efficacy of once daily fenofibrate-a well-tolerated, generic PPAR-alpha agonist widely used for dyslipidemia-in preventing clinically detectable rPSC after 36 months of treatment, compared to an untreated control group. (rPSC diagnosis based on established criteria outlined below).
This study also investigates novel serum biomarkers of biliary inflammation may serve as early signals of disease either as an alternative or an adjunct to alkaline phosphatase, and before biliary stricturing occurs. The study will also employ quantitative biliary flow dynamics with gadoxetate-enhanced margentic resonance imaging (MRI) which can identify early biliary strictures, hepatocyte function and onset of fibrosis is being studied as a modality to assess pre-transplant PSC severity.
rPSC diagnosis: The study utilizes established criteria for diagnosis of rPSC, with additional inclusion and exclusion criteria for more stringent rule-out of other post-transplant complications of the biliary tree, as follows.1 The criteria will be applied to patients who are between 1 and 7 years from LT.
- Explant findings consistent with PSC and
- Absence of untreated hepatic arterial thrombosis, stenosis, or other reason for diminished hepatic arterial resistive indices after LT, and
- Absence of ischemic cholangiopathy after LT, defined as the development of biliary strictures within the first year of LT as defined elsewhere32, and
- Absence of untreated biliary anastomotic (post-surgical) stricture, and
- Presence of intrahepatic and/or extrahepatic biliary stricturing characteristic of PSC by magnetic resonance cholangiography, endoscopic retrograde cholangiography, or percutaneous transhepatic cholangiography, and/or
- Liver biopsy with fibrous cholangitis and/or fibro-obliterative lesions with or without ductopenia, consistent with PSC
- Being tested
- Fenofibrate (drug), Blood draw for the laboratory assessment, MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)
- Keywords
- primary sclerosing cholangitis, recurrent primary sclerosing cholangitis, liver transplant complication, fenofibrate, fibrate, PPAR agonist, peroxisome proliferated activated receptor agonist
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate (drug)Drug
Once daily fenofibrate for 36 months
Blood draw for the laboratory assessmentDiagnostic test
Serum assessments will be performed every 3 months during the study period
MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)Diagnostic test
Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Individuals who underwent liver transplantation for primary sclerosing cholangitis 1-7 years before study initiation, and meeting study criteria, will receive fenofibrate 160mg oral daily for 36 months
Participants will undergo the following serum assessments as part of the study every 3 months during the study period: total bile acids, bile acid profile, fibroblast growth factor 19, and 7-alpha-C4
Participants will undergo gadoxate-enhanced magnetic resonance imaging at baseline, 12 months, and 36 months. Receives: Drug: Fenofibrate (drug); Diagnostic Test: Blood draw for the laboratory assessment; Diagnostic Test: MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) |
| Historical control | No intervention | Historical control of individuals who underwent liver transplantation for primary sclerosing cholangitis who were not treated with any peroxisome proliferator activated receptor agonist treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.
Proportion of recipients transplanted for PSC who develop rPSC during a 36-month fenofibrate treatment period, compared to the rate of rPSC in a untreated cohort. The diagnosis of rPSC will be made based on established diagnostic criteria (see Study Design)
Measured: 36 months
Secondary outcomes (6)
To quantify the associations between serum alkaline phosphatase and rPSC development in LT recipients treated with fenofibrate
Quantify the relative risk between serum alkaline phosphatase level (IU/L) and the diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of fenofibrate treatment
Measured: 36 months
To quantify the associations between total serum bile acid level and rPSC development in LT recipients treated with fenofibrate
Quantify the relative risk between total serum bile acid level (micromol/liter) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of treatment
Measured: 36 months
To quantify the associations between serum bile acid profile and rPSC development in LT recipients treated with fenofibrate
Quantify the relative risk between primary bile acids level (nanonmol/mL), secondary bile acid level (nanonmol/mL), and glycine:taurine conjugate bile acid level (nanonmol/mL) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of fenofibrate treatment
Measured: 36 months
To quantify the associations between fibroblast growth factor 19 level and rPSC development in LT recipients treated with fenofibrate
Quantify the relative risk between serum fibroblast growth factor 19 level (picogram/ml) with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of treatment
Measured: 36 months
To quantify the associations between serum 7-alpha-hydroxy-4-cholesten-3-one level and rPSC development in LT recipients treated with fenofibrate
Quantify the relative risk between serum 7-alpha-hydroxy-4-cholesten-3-one (7-alpha-C4) (nanogram/mL) levels with a diagnosis of rPSC (based on established diagnostic criteria - see Study Design) at 36 months of treatment
Measured: 36 months
To quantify the association between quantitative biliary flow dynamics demonstrated by gadoxetate-enhanced and T1 mapping magnetic resonance imaging with rPSC development in LT recipients treated with fenofibrate
The ANALI score, biliary transit time, and relative enhancement index of the hepatic parenchyma will be quantified by gadoxetate-enhanced MRI/MRCP. These measures will be correlated with the development of rPSC (based on established diagnostic criteria - see Study Design) during fenofibrate treatment period at 12 months, and 36 months.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Apr 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Channa R Jayasekera, MD, MSc, Mayo Clinic
- Investigators
- Channa Jayasekera, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905054
- Sponsor's protocol ID
- 24-007598
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06905054
- Acronym / sponsor ID
- 24-007598
- Keywords
- primary sclerosing cholangitis, recurrent primary sclerosing cholangitis, liver transplant complication, fenofibrate, fibrate, PPAR agonist, peroxisome proliferated activated receptor agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 Apr 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.
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
Detailed description
Primary sclerosing cholangitis (PSC), an immune-mediated, progressive cholestatic disease with no well-established pharmacologic treatment, has an annual incidence of 2.0 per 100,000 and is responsible for 5% of liver transplants (LT) performed in the United States. Recurrent PSC (rPSC) after LT occurs in 8-27% at 5 years and is associated with an over 40% risk of graft loss.
Because PSC patients undergo LT at a younger age than non-PSC patients (median 40-50 years vs 60 years for most other LT indications), rPSC poses significant lifetime morbidity and mortality risk, and development of its early signs of biliary injury, particularly the development cholestasis (elevated alkaline phosphatase), is routinely monitored in the post-transplant setting.
There is no established pharmacologic treatment for rPSC, and the disease is usually characterized by progressive cholestasis to biliary stricturing, cholangitis, allograft fibrosis and ultimately liver failure. Trials of ursodeoxycholic acid and oral vancomycin have been inconclusive. Since most transplants for PSC are performed with Roux-en-Y biliary reconstructions that make re-transplantation challenging, any pharmacologic intervention to reduce the risk of rPSC would represent a breakthrough in disease management.
Cholestasis appears to be a surrogate for PSC disease progression since improvement in alkaline phosphatase levels is associated with slower disease progression, lower rates of cholangiocarcinoma, and improved survival in the pre-transplant setting. Peroxisome proliferator-activated receptor (PPAR) agonists (e.g. fenofibrate, bezafibrate, seladelpar, elafibranor) reduce bile acid-mediated biliary injury by downregulating their synthesis and activity, and promoting choleresis. PPAR agonists have demonstrated efficacy in potently improving cholestasis in PSC pre-transplant, and other cholestatic liver diseases post-transplant.
While fibrates have been shown to improve both biochemical and clinical parameters of PSC in non-transplant patients, whether they can prevent clinically detectable rPSC after transplantation has not been studied. Extrapolating the pre-transplant data to the post-transplant setting, this study hypothesizes that mitigating cholestasis with the use of fibrates in transplant recipients may impede the development of rPSC.
In this study, the primary aim is to assess the efficacy of once daily fenofibrate-a well-tolerated, generic PPAR-alpha agonist widely used for dyslipidemia-in preventing clinically detectable rPSC after 36 months of treatment, compared to an untreated control group. (rPSC diagnosis based on established criteria outlined below).
This study also investigates novel serum biomarkers of biliary inflammation may serve as early signals of disease either as an alternative or an adjunct to alkaline phosphatase, and before biliary stricturing occurs. The study will also employ quantitative biliary flow dynamics with gadoxetate-enhanced margentic resonance imaging (MRI) which can identify early biliary strictures, hepatocyte function and onset of fibrosis is being studied as a modality to assess pre-transplant PSC severity.
rPSC diagnosis: The study utilizes established criteria for diagnosis of rPSC, with additional inclusion and exclusion criteria for more stringent rule-out of other post-transplant complications of the biliary tree, as follows.1 The criteria will be applied to patients who are between 1 and 7 years from LT.
- Explant findings consistent with PSC and
- Absence of untreated hepatic arterial thrombosis, stenosis, or other reason for diminished hepatic arterial resistive indices after LT, and
- Absence of ischemic cholangiopathy after LT, defined as the development of biliary strictures within the first year of LT as defined elsewhere32, and
- Absence of untreated biliary anastomotic (post-surgical) stricture, and
- Presence of intrahepatic and/or extrahepatic biliary stricturing characteristic of PSC by magnetic resonance cholangiography, endoscopic retrograde cholangiography, or percutaneous transhepatic cholangiography, and/or
- Liver biopsy with fibrous cholangitis and/or fibro-obliterative lesions with or without ductopenia, consistent with PSC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Fenofibrate (drug), Diagnostic Test: Blood draw for the laboratory assessment, Diagnostic Test: MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)Individuals who underwent liver transplantation for primary sclerosing cholangitis 1-7 years before study initiation, and meeting study criteria, will receive fenofibrate 160mg oral daily for 36 months Participants will undergo the following serum assessments as part of the study every 3 months during the study period: total bile acids, bile acid profile, fibroblast growth factor 19, and 7-alpha-C4 Participants will undergo gadoxate-enhanced magnetic resonance imaging at baseline, 12 months, and 36 months. |
| Historical control | No intervention | –Historical control of individuals who underwent liver transplantation for primary sclerosing cholangitis who were not treated with any peroxisome proliferator activated receptor agonist treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion/exclusion criteria.
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Fenofibrate (drug)Once daily fenofibrate for 36 months | Drug | Treatment |
| Blood draw for the laboratory assessmentSerum assessments will be performed every 3 months during the study period | Diagnostic test | Treatment |
| MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation. | Diagnostic test | Treatment |
Primary outcome
To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.
Time frame: 36 months
Proportion of recipients transplanted for PSC who develop rPSC during a 36-month fenofibrate treatment period, compared to the rate of rPSC in a untreated cohort. The diagnosis of rPSC will be made based on established diagnostic criteria (see Study Design)
6 secondary outcomes
To quantify the associations between serum alkaline phosphatase and rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
To quantify the associations between total serum bile acid level and rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
To quantify the associations between serum bile acid profile and rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
To quantify the associations between fibroblast growth factor 19 level and rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
To quantify the associations between serum 7-alpha-hydroxy-4-cholesten-3-one level and rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
To quantify the association between quantitative biliary flow dynamics demonstrated by gadoxetate-enhanced and T1 mapping magnetic resonance imaging with rPSC development in LT recipients treated with fenofibrate
Time frame: 36 months
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 17 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Channa Jayasekera principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate (drug), Blood draw for the laboratory assessment and MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) in people with Primary Sclerosing Cholangitis and Liver Transplant, Complications, run by Mayo Clinic at 1 site in United States.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort. (time frame: 36 months). 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 17 Jul 2026.