Chronic Hepatitis B
Conditions
Keywords
Metformin, Entecavir, chronic hepatitis B, hepatitis B virus
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.
Interventions
DRUGMetformin & Entecavir
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)
Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)
Sponsors
Jinan Military General Hospital
Fu-Sheng Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum HBsAg level | weeks 24 and 36 after adding metformin or a placebo | log IU/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index | weeks 24 and 36 after adding metformin or a placebo | kg/m\^2 |
| fasting glucose | weeks 24 and 36 after adding metformin or a placebo | mmol/L |
| weight | weeks 24 and 36 after adding metformin or a placebo | kg |
| triglycerides | weeks 24 and 36 after adding metformin or a placebo | mmol/L |
| total cholesterol | weeks 24 and 36 after adding metformin or a placebo | mmol/L |
| HbA1c | weeks 24 and 36 after adding metformin or a placebo | percentage (%) |
Countries
China
Outcome results
None listed