Recruiting NCT06365424

Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

Phase II / Phase III Interventional Primary Biliary Cholangitis

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, UDCA.
Who it may be relevant to: Registry conditions: Primary Biliary Cholangitis. 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 →

Official title

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects 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)

Treatment emergent adverse events (TEAEs) [Time frame: Through study completion, up to 120 Months]
Percentage of patients with biochemical response [Time frame: Through study completion, up to 120 Months]

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

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

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

Healthy volunteers: No

China · 1 center

NCT: NCT06365424 · KY20151230-5-1