Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
Phase 3
Withdrawn
- Conditions
- Hepatitis, Autoimmune
- Interventions
- Registration Number
- NCT02878863
- Lead Sponsor
- Xiaoli Fan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phosphatidylcholine or silymarin Phosphatidylcholine or silymarin Phosphatidylcholine or silymarin Paeoniflorin + phosphatidylcholine or silymarin Paeoniflorin + phosphatidylcholine or silymarin Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin
- Primary Outcome Measures
Name Time Method Percent of patients that achieve biochemical remission of AIH Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
- Secondary Outcome Measures
Name Time Method Alanine transaminase (ALT) Month 1, 3, 6 Aspartate transaminase(AST) Month 1, 3, 6 Immunoglobulin G(IgG) Month 1, 3, 6 Globin(GLB) Month 1, 3, 6 Total bilirubin(TB) Month 1, 3, 6 Direct bilirubin(DB) Month 1, 3, 6
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China