Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

Xijing Hospital of Digestive Diseases

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Primary Biliary Cholangitis

Treatments

Drug: Fenofibrate

Drug: UDCA

Study type

Interventional

Funder types

Other

Identifiers

KY20151230-5-1

Details and patient eligibility

About

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

Enrollment

117 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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