Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B

Fu-Sheng Wang60 enrolled

Overview

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B. Patients with chronic hepatitis B who met eligibility criteria were randomly assigned (1:1) to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24 weeks in addition to their ongoing entecavir therapy. Patients and investigators were both blinded to group allocation. The primary outcome, serum HBsAg level (log IU/mL) at weeks 24 and 36, was analysed using a linear mixed-effect model. The intention-to-treat populations were included in primary and safety analyses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

Metformin & EntecavirDRUG

Adding sustained-release metformin hydrochloride (1000 mg, oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)

Placebo & EntecavirDRUG

Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HBeAg-negative chronic hepatitis B * Ongoing treatment with Entecavir for more than 12 months * HBV DNA \< 500 IU/mL * Quantitative HBsAg \< 3 log IU/mL * ALT and AST \< 2 × upper limit of normal (ULN) * Agree to take contraceptive measures during participation for women of a fertile age * Agree not to engage in other clinical trials during participation * Understand and sign the informed consent form before taking any steps related to this study Exclusion Criteria: * Diabetes mellitus * Alcoholic liver disease * Drug-induced liver damage * Autoimmune liver disease * Decompensated cirrhosis * Liver cancer * Liver transplantation * Pregnant or lactating women * Other conditions unsuitable for participation

Locations (1)

The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital)

Tai’an, Shandong, China