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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo |
|
| Experimental group | Experimental | Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Liver inflammatory | Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score. | baseline and 24 weeks |
| Change of Liver Fibrosis | Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Magnesium Isoglycyrrhizinate | Drug | Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based |
|
|
| Diammonium Glycyrrhizinate | Drug | Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based |
|
|
| Magnesium Isoglycyrrhizinate Placebo | Drug | Magnesium Isoglycyrrhizinate Injection Placebo |
|
|
| Diammonium Glycyrrhizinate Placebo | Drug | Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo |
|
|
| baseline and 96 weeks |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006505 | Hepatitis |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| C521270 | 18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate |
| D019695 | Glycyrrhizic Acid |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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