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

Hepatitis, Autoimmune Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02878863
• Other study ID #: AIH-1
• Status: Withdrawn
• Phase: Phase 3
• First received: August 9, 2016
• Last updated: July 10, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Drug:
• Paeoniflorin + phosphatidylcholine or silymarin

• Phosphatidylcholine or silymarin

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoli Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Secondary	Alanine transaminase (ALT)		Month 1, 3, 6
Secondary	Aspartate transaminase(AST)		Month 1, 3, 6
Secondary	Immunoglobulin G(IgG)		Month 1, 3, 6
Secondary	Globin(GLB)		Month 1, 3, 6
Secondary	Total bilirubin(TB)		Month 1, 3, 6
Secondary	Direct bilirubin(DB)		Month 1, 3, 6