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

Fu-Sheng Wang

Status: Completed

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo & Entecavir; Drug: Metformin & Entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT04182321

960-2019-84

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Combination Therapy

Experimental group

Description:

Metformin as add-on to entecavir therapy in patients with chronic hepatitis B

Treatment:

Drug: Metformin & Entecavir

Standard Therapy

Placebo Comparator group

Description:

Entecavir monotherapy in patients with chronic hepatitis B

Treatment:

Drug: Placebo & Entecavir