Adding Metformin to the Standard Treatment for Patients With HBeAg-Negative Chronic Hepatitis B

Summary

Participation Requirements

Description

This is a single-center, randomized, placebo-controlled pilot study to assess the efficacy and safety of adding Metformin to the standard treatment for patients with HBeAg-positive chronic hepatitis B. Sixty subjects who meet the eligibility criteria will be randomized to the experimental arm and co...

This is a single-center, randomized, placebo-controlled pilot study to assess the efficacy and safety of adding Metformin to the standard treatment for patients with HBeAg-positive chronic hepatitis B. Sixty subjects who meet the eligibility criteria will be randomized to the experimental arm and comparator arm according to a 1:1 ratio. The participants in the experimental arm will be treated with Metformin (sustained release tablet, 1000 mg, once a day(QD), 24 weeks) and Entecavir (tablet, 0.5 mg, QD, ongoing treatment). The participants in the comparator arm will be treated with Placebo (two tablets, QD, 24 weeks) and Entecavir (tablet, 0.5 mg, QD, ongoing treatment). The primary endpoint for efficacy assessment is the cumulative rate of HBsAg loss at week 36 after enrollment; the secondary endpoint for efficacy assessment is the decrease in quantitative HBsAg from the baseline at week 36 after enrollment. The secondary endpoint for safety assessment is the cumulative incidence of adverse events at week 36 after enrollment.

Tracking Information