Chronic Hepatitis b, Liver Inflammation
Conditions
Keywords
necro-inflammatory, glycyrrhizin, entecavir, hepatic biological parameters, liver fibrosis
Brief summary
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.
Detailed description
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.
Interventions
DRUGEntecavir
Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
DRUGMagnesium Isoglycyrrhizinate Placebo
Magnesium Isoglycyrrhizinate Injection Placebo
DRUGDiammonium Glycyrrhizinate Placebo
Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Sponsors
Cttq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of ALT(Alanine aminotransferase) | baseline and 24 weeks | The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Liver inflammatory | baseline and 24 weeks | Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score. |
| Change of Liver Fibrosis | baseline and 96 weeks | Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination. |
Outcome results
None listed