Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaoli Fan
• Treatments: Immunosuppressive Agents; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• 1.Patients aged 18-70 years;

• 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;

• 3.White blood cell count ≥2.5x10^9/L or platelet count ≥50x10^9/L at inclusion;

• 4.Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

• 1. The presence of hepatitis A, B, C, D, or E virus infection;

• 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.

• 3. Patients with complications of cirrhosis;

• 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;

• 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;

• 6. Pregnant and breeding women;

• 7. Severe disorders of other vital organs, such as severe heart failure, cancer;

• 8. Parenteral administration of blood or blood products within 6 months before screening;

• 9. Recent treatment with drugs having known liver toxicity;

• 10.Taken part in other clinic trials within 6 months before screening.