Using Fenofibrate to treat 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 study evaluates the safety and effectiveness of Fenofibrate in patients diagnosed with Primary Biliary Cholangitis (PBC). It is an open-label, long-term interventional study that includes participants who have previously taken part in another PBC study involving Fenofibrate. The study aims to gather data on how well Fenofibrate works in managing this liver condition over an extended period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have given written informed consent (signed and dated)
* Participated in the PBC study with fenofibrate (NCT02823353)
* Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

* Treatment-related adverse event (AE) leading to fenofibrate discontinuation
* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
* Known history of other liver diseases
* For females, pregnancy or breast-feeding
* Long-term use of immunosuppressive agents
* 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

• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Yansheng Liu, MD
• Email: liuyansheng506@163.com
• Phone: +862984771539

Similar studies

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

• Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)

  This study tests whether combining seladelpar with cilofexor helps people with primary biliary cholangitis more than seladelpar alone or placebo.

  Recruiting at 4 sites Phase 2 Gilead Sciences · Colorado Springs, Colorado and 3 other locations · NCT07841977

• Austrian PBC Registry

  This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.

  Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

  This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.

  Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

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

  This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.

  Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

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

  This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.

  Recruiting at 3 sites Phase 3 Zydus Therapeutics Inc. · Marietta, Georgia and 2 other locations · NCT07216235

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.