Status:
ENROLLING_BY_INVITATION
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Lead Sponsor:
Han Ying
Conditions:
Primary Biliary Cholangitis (PBC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet ...
Eligibility Criteria
Inclusion
- Voluntarily joining the group, able to understand and sign an informed consent form;
- 18 years old ≤ age ≤ 75 years old;
- The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct;
- Liver histology suggests moderate to severe interfacial hepatitis (moderate,\<50% portal or fibrous septa destruction, severe,\>50% portal or fibrous septa destruction) with serum ALT\<5 \* ULN, serum IgG\<2 \* ULN, and negative serum anti smooth muscle antibodies;
- Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment;
- ALP\>1.67 \* ULN.
Exclusion
- 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
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06591468
Start Date
October 30 2024
End Date
December 31 2027
Last Update
November 28 2025
Active Locations (2)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
2
Xijing hospital
Xi'an, Shaanxi, China, 710032