Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B

Cttq480 enrolled

Overview

This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.

Chronic hepatitis B(HBV) has a high prevalence (\>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase. Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. The addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic HBV and advanced fibrosis or cirrhosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Chronic Hepatitis b Liver Inflammation

Interventions

EntecavirDRUG

Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based

Magnesium IsoglycyrrhizinateDRUG

Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based

Diammonium GlycyrrhizinateDRUG

Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hepatitis B surface antigen \[HBsAg\]-positive, * Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible, * Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels\<2×ULN Exclusion Criteria: * Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus; * Other forms of liver disease; * More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization; * More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin; * Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC); * During the study patients were not allowed to use other medicines.

Outcomes

Primary Outcomes

Change of ALT(Alanine aminotransferase)

The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L.

Time frame: baseline and 24 weeks

Secondary Outcomes

Change of Liver inflammatory

Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score.

Time frame: baseline and 24 weeks

Change of Liver Fibrosis

Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.

Time frame: baseline and 96 weeks

Data from ClinicalTrials.gov

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