Primary Biliary Cholangitis (PBC)
Conditions
Brief summary
This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.
Interventions
DRUGFenofibrate
Fenofibrate 200mg/day
UDCA 13-15mg/kg/day
Sponsors
Han Ying
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 provided written informed consent * Age 18-75 years; * BMI 17-28 kg/m2 * Male or female with a diagnosis of PBC, by at least two of the following criteria: 1. History of AP above ULN for at least six months; 2. Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies; 3. Documented liver biopsy result consistent with PBC. * Not receiving UDCA treatment before enrollment, ALP\>ULN
Exclusion criteria
* History or presence of other concomitant liver diseases. * ALT or AST \> 5×ULN, TBIL \> 3×ULN. * If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * Allergic to fenofibrate or ursodeoxycholic acid. * Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. * Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min. * Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * Planned to receive an organ transplant or an organ transplant recipient. * Needing Liver transplantation within 1 year according to the Mayo Rick score. * Any other condition(s) that would compromise the safety of the subject or compromise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with biochemical response | 6 months | The normalisation of Alkaline Phosphatase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients having biochemical response | 1 and 3 months | The normalisation of Alkaline Phosphatase |
| Assessment of the pruritus | 6 months | Change From Baseline in Pruritus as Assessed by NRS Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome) |
| The changes of liver function indicators | 1, 3 and 6 months | The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBA, TBIL |
| The percentage of patients achieving biochemical response criteria | 1, 3 and 6 months | The percentage of patients who meet various biochemical response criteria (Paris I, Paris II, and Barcelona, etc.) |
| Prognostic score | 1, 3 and 6 month | GLOBE score |
| Liver stiffness (LSM) | 1, 3 and 6 months | Evaluate the changes in LSM |
| Event-free survival | From enrollment to the end of treatment at 6 months | Liver transplantation and decompensation events-free survival |
Countries
China
Outcome results
None listed