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

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ClinicalTrials.gov Identifier: NCT03349008
Recruitment Status : Unknown
Verified November 2017 by Cttq.
Recruitment status was:  Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Cttq

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Liver Inflammation Drug: Entecavir Drug: Magnesium Isoglycyrrhizinate Drug: Diammonium Glycyrrhizinate Drug: Magnesium Isoglycyrrhizinate Placebo Drug: Diammonium Glycyrrhizinate Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


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 Name: Entecavir Pill

Drug: Magnesium Isoglycyrrhizinate Placebo
Magnesium Isoglycyrrhizinate Injection Placebo
Other Name: Magnesium Isoglycyrrhizinate Injection Placebo

Drug: Diammonium Glycyrrhizinate Placebo
Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Other Name: 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 Name: Entecavir Pill

Drug: Magnesium Isoglycyrrhizinate
Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
Other Name: Magnesium Isoglycyrrhizinate Injection

Drug: Diammonium Glycyrrhizinate
Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
Other Name: Diammonium Glycyrrhizinate Enteric-coated Capsules




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change of Liver Fibrosis [ Time Frame: baseline and 96 weeks ]
    Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT03349008    
Other Study ID Numbers: Cttq-MAGIC-101
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cttq:
necro-inflammatory
glycyrrhizin
entecavir
hepatic biological parameters
liver fibrosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Inflammation
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Glycyrrhizic Acid
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents