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

July 10, 2017 updated by: Xiaoli Fan

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paeoniflorin + phosphatidylcholine or silymarin
Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin
Drug: Paeoniflorin + phosphatidylcholine or silymarin
Other Names:
  • total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin
Active Comparator: Phosphatidylcholine or silymarin
Drug: Phosphatidylcholine or silymarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients that achieve biochemical remission of AIH
Time Frame: 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
Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only

Secondary Outcome Measures

Outcome Measure
Time Frame
Alanine transaminase (ALT)
Time Frame: Month 1, 3, 6
Month 1, 3, 6
Aspartate transaminase(AST)
Time Frame: Month 1, 3, 6
Month 1, 3, 6
Immunoglobulin G(IgG)
Time Frame: Month 1, 3, 6
Month 1, 3, 6
Globin(GLB)
Time Frame: Month 1, 3, 6
Month 1, 3, 6
Total bilirubin(TB)
Time Frame: Month 1, 3, 6
Month 1, 3, 6
Direct bilirubin(DB)
Time Frame: Month 1, 3, 6
Month 1, 3, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoli Fan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 21, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIH-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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