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

Primary Purpose

Chronic Hepatitis b, Liver Inflammation

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Entecavir
Magnesium Isoglycyrrhizinate
Diammonium Glycyrrhizinate
Magnesium Isoglycyrrhizinate Placebo
Diammonium Glycyrrhizinate Placebo
Sponsored by
Cttq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring necro-inflammatory, glycyrrhizin, entecavir, hepatic biological parameters, liver fibrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change of Liver inflammatory
    Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score.
    Change of Liver Fibrosis
    Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.

    Full Information

    First Posted
    May 4, 2017
    Last Updated
    November 16, 2017
    Sponsor
    Cttq
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03349008
    Brief Title
    Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
    Acronym
    MAGIC-101
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 25, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    May 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cttq

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis b, Liver Inflammation
    Keywords
    necro-inflammatory, glycyrrhizin, entecavir, hepatic biological parameters, liver fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate
    Intervention Type
    Drug
    Intervention Name(s)
    Entecavir
    Other Intervention Name(s)
    Entecavir Pill
    Intervention Description
    Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Isoglycyrrhizinate
    Other Intervention Name(s)
    Magnesium Isoglycyrrhizinate Injection
    Intervention Description
    Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
    Intervention Type
    Drug
    Intervention Name(s)
    Diammonium Glycyrrhizinate
    Other Intervention Name(s)
    Diammonium Glycyrrhizinate Enteric-coated Capsules
    Intervention Description
    Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Isoglycyrrhizinate Placebo
    Other Intervention Name(s)
    Magnesium Isoglycyrrhizinate Injection Placebo
    Intervention Description
    Magnesium Isoglycyrrhizinate Injection Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Diammonium Glycyrrhizinate Placebo
    Other Intervention Name(s)
    Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
    Intervention Description
    Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
    Primary Outcome Measure Information:
    Title
    Change of ALT(Alanine aminotransferase)
    Description
    The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L.
    Time Frame
    baseline and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change of Liver inflammatory
    Description
    Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score.
    Time Frame
    baseline and 24 weeks
    Title
    Change of Liver Fibrosis
    Description
    Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.
    Time Frame
    baseline and 96 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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