Using fenofibrate with ursodeoxycholic acid to treat primary biliary cholangitis

Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis

This study is testing if adding fenofibrate to the usual treatment with ursodeoxycholic acid can help people with primary biliary cholangitis who aren't getting better with just the standard medication.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 9 sites (Lanzhou, Gansu and 8 other locations)
• Trial ID: NCT06174402 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of fenofibrate in combination with ursodeoxycholic acid (UDCA) on serum alkaline phosphatase levels in patients diagnosed with primary biliary cholangitis (PBC). Participants will be assessed for safety and efficacy over the course of the trial. The study aims to determine if fenofibrate can improve treatment outcomes for patients who have not responded adequately to UDCA alone. It includes both Phase 2 and Phase 3 assessments to ensure comprehensive evaluation of the treatment's impact.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of primary biliary cholangitis and an incomplete response to UDCA.

Not a fit: Patients with other liver diseases or those who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with primary biliary cholangitis who do not respond sufficiently to current standard treatments.

How similar studies have performed: Other studies have explored the use of fenofibrate in liver diseases, showing promising results, but this specific combination approach is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* Must have provided written informed consent
* Age 18-75 years;
* BMI 17-28 kg/m2
* Male or female with a diagnosis of PBC, by at least two of the following criteria:

  1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
  2. Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.
* Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT or AST \> 5×ULN, total bilirubin（TBIL） \> 3×ULN.
* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
* Allergic to fenofibrate or ursodeoxycholic acid.
* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.

Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.

* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
* Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
* Planned to receive an organ transplant or an organ transplant recipient.
* Needing Liver transplantation within 1 year according to the Mayo Rick score.
* Any other condition(s) that would compromise the safety of the subject or compromise

Where this trial is running

Lanzhou, Gansu and 8 other locations

• The second hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Nanjing Second Hospital — Nanjing, Jiangsu, China (Recruiting)
• Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China (Recruiting)
• Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
• Yan'an University Affiliated Hospital — Yan'an, Shanxxi, China (Recruiting)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Conditions Primary Biliary Cholangitis