Primary Biliary Cholangitis
Conditions
Brief summary
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Interventions
DRUGFenofibrate
Fenofibrate (200 mg/day)
DRUGUDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events (TEAEs) | Through study completion, up to 120 Months | — |
| Percentage of patients with biochemical response | Through study completion, up to 120 Months | The normalisation of Alkaline Phosphatase |
Countries
China
Contacts
Primary ContactYansheng Liu, MD
Outcome results
None listed