Combining fenofibrate with ursodeoxycholic acid for treating primary biliary cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of fenofibrate in combination with ursodeoxycholic acid (UDCA) for patients with primary biliary cholangitis (PBC) who do not respond adequately to UDCA alone. The study employs a multi-center, randomized, placebo-controlled design, administering either fenofibrate or a placebo alongside UDCA for 48 months. The primary goal is to achieve complete normalization of alkaline phosphatase (ALP) and total bilirubin (TBIL) levels, while secondary outcomes include monitoring adverse events and assessing liver health over time. The trial also aims to refine criteria for identifying patients who may benefit from additional therapies earlier in their treatment.

Why it matters

Who can join: the full rules

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:

  * History of AP above ULN for at least six months;
  * Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  * Documented liver biopsy result consistent with PBC.
* Incomplete response to UDCA defined by Xi'an criteria (ALP \>2.5× ULN, AST\>2×ULN or TBIL\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT/AST \> 5×ULN, 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 the quality of the clinical study, as judged by the Investigator.

Where it's running

• The second hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• The First Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting
• Ying han
  Xi'an, Shaanxi, China Recruiting
• Sichuan Provincial People's Hospital,
  Chengdu, Sichuan, China Recruiting
• Tianjin Medical University General Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Ying Han, Doctor — The First Affiliated Hospital of Air Force Medical University
• Study coordinator: Yulong Shang
• Email: shangyl870222@163.com
• Phone: +86 18629661032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

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• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

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• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.