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

Chronic Hepatitis b Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03349008
• Other study ID #: Cttq-MAGIC-101
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 4, 2017
• Last updated: November 16, 2017
• Start date: November 25, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: November 2017
• Source: Cttq
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Inflammation
• Liver Inflammation

Intervention

Drug:
• Entecavir
Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
• Magnesium Isoglycyrrhizinate
Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
• Diammonium Glycyrrhizinate
Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
• Magnesium Isoglycyrrhizinate Placebo
Magnesium Isoglycyrrhizinate Injection Placebo
• Diammonium Glycyrrhizinate Placebo
Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cttq

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Liver inflammatory	Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score.	baseline and 24 weeks
Secondary	Change of Liver Fibrosis	Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.	baseline and 96 weeks