Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
China53 participantsStarted 2016-12
Plain-language summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
Timeframe: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents