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

Xiaoli Fan

Status and phase

Withdrawn

Phase 3

Conditions

Hepatitis, Autoimmune

Treatments

Drug: Paeoniflorin + phosphatidylcholine or silymarin

Drug: Phosphatidylcholine or silymarin

Study type

Interventional

Funder types

Other

Identifiers

NCT02878863

AIH-1

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 70 years old

Volunteers

No 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.