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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis, Autoimmune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paeoniflorin + phosphatidylcholine or silymarin

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

Group Type EXPERIMENTAL

Paeoniflorin + phosphatidylcholine or silymarin

Intervention Type DRUG

Phosphatidylcholine or silymarin

Group Type ACTIVE_COMPARATOR

Phosphatidylcholine or silymarin

Intervention Type DRUG

Interventions

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Paeoniflorin + phosphatidylcholine or silymarin

Intervention Type DRUG

Phosphatidylcholine or silymarin

Intervention Type DRUG

Other Intervention Names

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total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No