Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
NCT ID: NCT02936596
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
53 participants
INTERVENTIONAL
2016-12-31
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ursodeoxycholic acid + immunosuppressive agents group
Ursodeoxycholic acid + immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
Ursodeoxycholic acid group
Ursodeoxycholic acid
Ursodeoxycholic Acid
Ursodeoxycholic Acid
Interventions
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Ursodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
Ursodeoxycholic Acid
Ursodeoxycholic Acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Xiaoli Fan
OTHER
Responsible Party
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Xiaoli Fan
Master Degree
Principal Investigators
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Li Yang, MD
Role: STUDY_CHAIR
West China Hospital,Chengdu, Sichuan, China
Locations
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West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoli Fan, MM
Role: primary
Li Yang, MD
Role: backup
Other Identifiers
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OS-1
Identifier Type: -
Identifier Source: org_study_id