Overview

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.