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Recruiting Phase 2/3

Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

NCT06365424 · tracked via the Priya Life Science China tracker
Phase
Phase 2/3
Started
2017-04-08
Last updated
2026-10-30

Condition(s) studied

Primary Biliary Cholangitis

Investigational drug(s) / intervention(s)

Fenofibrate →UDCA →

Fenofibrate: Fenofibrate (200 mg/day)

UDCA: Ursodeoxycholic acid (13-15 mg/kg/day)

Study summary

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Treatment emergent adverse events (TEAEs) — Through study completion, up to 120 Months
  • Percentage of patients with biochemical response — Through study completion, up to 120 Months
    The normalisation of Alkaline Phosphatase

Trial sites (1)

FacilityCityRegionStatus
Xijing Hospital Xi'an Shaanxi Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06365424 on ClinicalTrials.gov ↗ ← All trials in China