Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B (MAGIC-101)

CTTQ

Status and phase: Unknown; Phase 4

Conditions: Liver Inflammation; Chronic Hepatitis b

Treatments: Drug: Diammonium Glycyrrhizinate Placebo; Drug: Magnesium Isoglycyrrhizinate Placebo; Drug: Magnesium Isoglycyrrhizinate; Drug: Diammonium Glycyrrhizinate; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03349008

Cttq-MAGIC-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

480 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Entecavir

Drug: Magnesium Isoglycyrrhizinate Placebo

Drug: Diammonium Glycyrrhizinate Placebo

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Diammonium Glycyrrhizinate

Drug: Entecavir

Drug: Magnesium Isoglycyrrhizinate