Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis

Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis

NCT02878863•Xiaoli Fan

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Summary

An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged 20-70 years;
•Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
•High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
•High levels of IgG(1-1.5 X ULN);
•Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
•Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria

•The presence of hepatitis A, B, C, D, or E virus infection;
•Patients with presence of liver cirrhosis or portal hypertension;
•Patients with presence of fulminant liver failure;
•Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
•Pregnant and breeding women;
•Severe disorders of other vital organs, such as severe heart failure, cancer;
•Parenteral administration of blood or blood products within 6 months before screening;
•Recent treatment with drugs having known liver toxicity;
•Taken part in other clinic trials within 6 months before screening.

Locations (1)

West China Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

August 1, 2016

Primary Completion Date

March 1, 2017

Completion Date

July 1, 2017

Last Updated

July 13, 2017

Conditions

Hepatitis, Autoimmune

Interventions

Paeoniflorin + phosphatidylcholine or silymarin

DRUG

Phosphatidylcholine or silymarin

DRUG

Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

NCT04376528

Hepatitis, AutoimmunePrimary Biliary Cholangitis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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