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Recruiting NCT06755151

Fenofibrate in Primary Biliary Cholangitis: a Real World Study

Phase III Interventional Primary Biliary Cholangitis (PBC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fenofibrate.
Who it may be relevant to
Registry conditions: Primary Biliary Cholangitis (PBC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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)

Interventions

  • Drug Fenofibrate
    Fenofibrate 200mg

Primary outcome measures

  • Treatment emergent adverse events (TEAEs) [Time frame: Through study completion, up to 120 Months]
Secondary outcome measures (3)
  • Death [Time frame: 120 months]
  • Liver transplantation [Time frame: 120 months]
  • Normalization of ALP [Time frame: 120 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xijing hospital — Xi'an

Identifiers

NCT: NCT06755151 · KY20232219-C-1-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗