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

Primary Purpose

Hepatitis, Autoimmune

Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paeoniflorin + phosphatidylcholine or silymarin
Phosphatidylcholine or silymarin
Sponsored by
Xiaoli Fan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis, Autoimmune

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paeoniflorin + phosphatidylcholine or silymarin

Phosphatidylcholine or silymarin

Arm Description

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

Phosphatidylcholine or silymarin

Outcomes

Primary Outcome Measures

Percent of patients that achieve biochemical remission of AIH
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits

Secondary Outcome Measures

Alanine transaminase (ALT)
Aspartate transaminase(AST)
Immunoglobulin G(IgG)
Globin(GLB)
Total bilirubin(TB)
Direct bilirubin(DB)

Full Information

First Posted
August 9, 2016
Last Updated
July 10, 2017
Sponsor
Xiaoli Fan
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1. Study Identification

Unique Protocol Identification Number
NCT02878863
Brief Title
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
Official Title
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoli Fan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Autoimmune

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paeoniflorin + phosphatidylcholine or silymarin
Arm Type
Experimental
Arm Description
Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin
Arm Title
Phosphatidylcholine or silymarin
Arm Type
Active Comparator
Arm Description
Phosphatidylcholine or silymarin
Intervention Type
Drug
Intervention Name(s)
Paeoniflorin + phosphatidylcholine or silymarin
Other Intervention Name(s)
total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin
Intervention Type
Drug
Intervention Name(s)
Phosphatidylcholine or silymarin
Primary Outcome Measure Information:
Title
Percent of patients that achieve biochemical remission of AIH
Description
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
Time Frame
Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Secondary Outcome Measure Information:
Title
Alanine transaminase (ALT)
Time Frame
Month 1, 3, 6
Title
Aspartate transaminase(AST)
Time Frame
Month 1, 3, 6
Title
Immunoglobulin G(IgG)
Time Frame
Month 1, 3, 6
Title
Globin(GLB)
Time Frame
Month 1, 3, 6
Title
Total bilirubin(TB)
Time Frame
Month 1, 3, 6
Title
Direct bilirubin(DB)
Time Frame
Month 1, 3, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
West China Hospital,Chengdu, Sichuan, China
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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