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

NCT ID: NCT03349008

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-25

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis b Liver Inflammation

Keywords

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necro-inflammatory glycyrrhizin entecavir hepatic biological parameters liver fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo

Group Type PLACEBO_COMPARATOR

Entecavir

Intervention Type DRUG

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

Magnesium Isoglycyrrhizinate Placebo

Intervention Type DRUG

Magnesium Isoglycyrrhizinate Injection Placebo

Diammonium Glycyrrhizinate Placebo

Intervention Type DRUG

Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo

Experimental group

Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

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

Magnesium Isoglycyrrhizinate

Intervention Type DRUG

Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based

Diammonium Glycyrrhizinate

Intervention Type DRUG

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

Interventions

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Entecavir

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

Intervention Type DRUG

Magnesium Isoglycyrrhizinate

Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based

Intervention Type DRUG

Diammonium Glycyrrhizinate

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

Intervention Type DRUG

Magnesium Isoglycyrrhizinate Placebo

Magnesium Isoglycyrrhizinate Injection Placebo

Intervention Type DRUG

Diammonium Glycyrrhizinate Placebo

Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo

Intervention Type DRUG

Other Intervention Names

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Entecavir Pill Magnesium Isoglycyrrhizinate Injection Diammonium Glycyrrhizinate Enteric-coated Capsules Magnesium Isoglycyrrhizinate Injection Placebo Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cttq

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Cttq-MAGIC-101

Identifier Type: -

Identifier Source: org_study_id