Primary Biliary Cholangitis (PBC)
Conditions
Brief summary
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
DRUGFenofibrate
Fenofibrate 200mg
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Must have given written informed consent (signed and dated) 2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402) 3. ALP\> 1\*ULN 4. 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
1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events (TEAEs) | Through study completion, up to 120 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 120 months | Occurrence of overall death |
| Liver transplantation | 120 months | — |
| Normalization of ALP | 120 months | Proportion of subjects with normalization of ALP |
Countries
China
Contacts
Primary ContactYansheng Liu
Outcome results
None listed