NCT03349008

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2017

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

November 25, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

May 4, 2017

Last Update Submit

November 16, 2017

Conditions

Chronic Hepatitis bLiver Inflammation

Keywords

necro-inflammatoryglycyrrhizinentecavirhepatic biological parametersliver fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change of Liver inflammatory

    baseline and 24 weeks

  • Change of Liver Fibrosis

    baseline and 96 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: EntecavirDrug: Magnesium Isoglycyrrhizinate PlaceboDrug: Diammonium Glycyrrhizinate Placebo

Experimental group

EXPERIMENTAL

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

Drug: EntecavirDrug: Magnesium IsoglycyrrhizinateDrug: Diammonium Glycyrrhizinate

Interventions

EntecavirDRUG

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

Also known as: Entecavir Pill
Control groupExperimental group
Magnesium IsoglycyrrhizinateDRUG

Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based

Also known as: Magnesium Isoglycyrrhizinate Injection
Experimental group
Diammonium GlycyrrhizinateDRUG

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

Also known as: Diammonium Glycyrrhizinate Enteric-coated Capsules
Experimental group
Magnesium Isoglycyrrhizinate PlaceboDRUG

Magnesium Isoglycyrrhizinate Injection Placebo

Also known as: Magnesium Isoglycyrrhizinate Injection Placebo
Control group
Diammonium Glycyrrhizinate PlaceboDRUG

Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo

Also known as: Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitisLiver Cirrhosis

Interventions

entecavir18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrateGlycyrrhizic Acid

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Intervention Hierarchy (Ancestors)

Pentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

November 21, 2017

Study Start

November 25, 2017

Primary Completion

December 31, 2019

Study Completion

May 31, 2020

Last Updated

November 21, 2017

Record last verified: 2017-11