NCT03349008

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Cttq · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis b
• Liver Inflammation

Interventions

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

Timeline

• Start date: 2017-11-25
• Primary completion: 2019-12-31
• Completion: 2020-05-31
• First posted: 2017-11-21
• Last updated: 2017-11-21