Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B (MAGIC-101)

November 16, 2017 updated by: Cttq

The Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection Followed by Diammonium Glycyrrhizinate Enteric-coated Capsules and Combined With Entecavir on the Treatment of Chronic Hepatitis B

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo
Drug: Entecavir
Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
Other Names:
  • Entecavir Pill
Drug: Magnesium Isoglycyrrhizinate Placebo
Magnesium Isoglycyrrhizinate Injection Placebo
Other Names:
  • Magnesium Isoglycyrrhizinate Injection Placebo
Drug: Diammonium Glycyrrhizinate Placebo
Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Other Names:
  • Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Experimental: Experimental group
Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate
Drug: Entecavir
Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
Other Names:
  • Entecavir Pill
Drug: Magnesium Isoglycyrrhizinate
Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
Other Names:
  • Magnesium Isoglycyrrhizinate Injection
Drug: Diammonium Glycyrrhizinate
Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
Other Names:
  • Diammonium Glycyrrhizinate Enteric-coated Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ALT(Alanine aminotransferase)
Time Frame: 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.
baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Liver inflammatory
Time Frame: baseline and 24 weeks
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
Time Frame: baseline and 96 weeks
Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.
baseline and 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cttq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 25, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cttq-MAGIC-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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