Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B: A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Metformin & Entecavir
- Conditions
- Chronic Hepatitis B
- Sponsor
- Fu-Sheng Wang
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- serum HBsAg level
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Fu-Sheng Wang
Study Chair
Beijing 302 Hospital
Eligibility Criteria
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
Arms & Interventions
Combination Therapy
Metformin as add-on to entecavir therapy in patients with chronic hepatitis B
Intervention: Metformin & Entecavir
Standard Therapy
Entecavir monotherapy in patients with chronic hepatitis B
Intervention: Placebo & Entecavir
Outcomes
Primary Outcomes
serum HBsAg level
Time Frame: weeks 24 and 36 after adding metformin or a placebo
log IU/mL
Secondary Outcomes
- triglycerides(weeks 24 and 36 after adding metformin or a placebo)
- weight(weeks 24 and 36 after adding metformin or a placebo)
- body mass index(weeks 24 and 36 after adding metformin or a placebo)
- fasting glucose(weeks 24 and 36 after adding metformin or a placebo)
- HbA1c(weeks 24 and 36 after adding metformin or a placebo)
- total cholesterol(weeks 24 and 36 after adding metformin or a placebo)