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NCT Number: NCT06755151

Fenofibrate in Primary Biliary Cholangitis: a Real World Study

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

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Key information

Conditions

Primary Biliary Cholangitis (PBC) 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 3

Primary location

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)
  • Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
  • ALP> 1*ULN
  • 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 study drug discontinuation in a previous PBC study with seladelpar
  • A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results

Treatment and study plan

fenofibrate

Drug

Fenofibrate 200mg

Primary outcomes

  1. Treatment emergent adverse events (TEAEs)

    Time frame: Through study completion, up to 120 Months

Secondary outcomes

  1. Death

    Time frame: 120 months

    Occurrence of overall death

  2. Liver transplantation

    Time frame: 120 months

  3. Normalization of ALP

    Time frame: 120 months

    Proportion of subjects with normalization of ALP

Study contacts

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

Yansheng Liu

CONTACT

[email protected]

862984771509

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 Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
Jan 1, 2025
Registry last updated
Jan 8, 2026

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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