Trial | NCT02878863  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Aug 31
2016
Primary Completion
Mar 31
2017
Anticipated
Study Completion
Jul 31
2017
Anticipated
Last Update
Jul 13
2017

Drug Paeoniflorin + phosphatidylcholine or silymarin

  • Other names: total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin

Drug Phosphatidylcholine or silymarin

Paeoniflorin + phosphatidylcholine or silymarin Experimental

Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin

Phosphatidylcholine or silymarin Active Comparator

Phosphatidylcholine or 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.
No Results Posted