Fenofibrate added to UDCA for people with primary biliary cirrhosis not fully responding to UDCA

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 phase 3, randomized, open-label study evaluates whether adding fenofibrate to ongoing UDCA therapy improves liver biochemistry and clinical outcomes in patients with primary biliary cirrhosis who have not achieved a complete biochemical response to UDCA. Participants continue UDCA and are assigned to receive fenofibrate in addition to their current treatment. The study focuses on cholestasis-related markers and safety in a population with documented PBC. Eligibility requires prior UDCA use, specific serologic or histologic criteria, and the absence of major exclusion conditions such as decompensated liver disease or other hepatotoxic exposures. The trial is conducted at Xijing Hospital in Xi’an, China, under lead sponsorship by Xijing Hospital of Digestive Diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent
2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST or ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.
3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.

Exclusion Criteria:

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fenofibrate anaphylaxis.

Where it's running

• Xijing Hosipital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Ying Han, Ph.D
• Email: hanying@fmmu.edu.cn
• Phone: 86-29-84771539

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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.