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

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaoli Fan
• Treatments: Peoniflorin; Silymarin

Criteria

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.