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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fu-Sheng Wang
• Collaborator: Jinan Military General Hospital
• Treatments: Entecavir; Metformin

Criteria

Inclusion Criteria:

• HBeAg negative chronic hepatitis B

• Ongoing treatment with Entecavir for more than 12 months

• HBV DNA < 500 IU/mL

• Quantitative HBsAg < 1000 IU/mL

• Alanine aminotransferase (ALT) < 2 × upper limit of normal (ULN)

• Agreed to take contraceptive measures during participation for women of a fertile age

• Agreed not to engage in other clinical trials during participation

• Understood and signed 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

• Liver cirrhosis

• Liver cancer

• Liver transplantation

• Pregnant or lactating women

• Other conditions judged by investigators unsuitable for participation