Primary Biliary Cholangitis (PBC)
Conditions
Brief summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate 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
* Must have provided written informed consent * Age 18-75 years; * BMI 17-28 kg/m2 * Completed in a PBC study with fenofibrate(NCT06591455)
Exclusion criteria
* Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.; * Transaminases \>5 x ULN or total bilirubin \>3 x ULN; * Pregnant or breastfeeding women, or women planning to conceive during the study period; * Allergy to fenofibrate or ursodeoxycholic acid; * Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use; * Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously; * History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse); * Creatinine \>1.5 x ULN and creatinine clearance \<60 mL/min; * Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen); * Planned organ transplantation or previous organ transplantation; * Need for liver transplantation within 1 year according to the Mayo risk score; * Any other condition considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events (TEAEs) | Through study completion, up to 120 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalization of ALP | From enrollment to the end of treatment at 120 months | Percentage of patients having normalization of ALP |
| The changes of liver function indicators | From enrollment to the end of treatment at 120 months | The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBIL |
| The percentage of patients achieving biochemical response criteria | From enrollment to the end of treatment at 120 months | The percentage of patients who meet various biochemical response criteria (Paris I, Paris II, and Barcelona, etc.) |
| Death | From enrollment to the end of treatment at 120 months | Occurrence of overall death |
| Liver transplantation | From enrollment to the end of treatment at 120 months | Occurrence of overall liver transplantation |
Countries
China
Outcome results
None listed