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

• Status: Unknown status
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cttq
• Treatments: Entecavir; Glycyrrhizic Acid

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.