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NCT Number: NCT06365424

Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

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

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Key information

Conditions

Primary Biliary Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xijing Hospital

Xi'an, Shaanxi, China

Location status: Recruiting

Location contact

Ying Han

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

Fenofibrate (200 mg/day)

UDCA

Drug

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

Primary outcomes

  1. Treatment emergent adverse events (TEAEs)

    Time frame: Through study completion, up to 120 Months

  2. Percentage of patients with biochemical response

    Time frame: Through study completion, up to 120 Months

    The normalisation of Alkaline Phosphatase

Study contacts

Contact information is provided by the study sponsor or research team.

Yansheng Liu, MD

CONTACT

[email protected]

+862984771539

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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