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

Not Applicable

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Metformin & Entecavir; Drug: Placebo & Entecavir

• Registration Number: NCT04182321
• Lead Sponsor: Fu-Sheng Wang

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.

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Study Start: 2020-03-13
• Primary Completion: 2021-07-02
• Study Completion: 2021-09-13
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Metformin & Entecavir	Metformin as add-on to entecavir therapy in patients with chronic hepatitis B
Standard Therapy	Placebo & Entecavir	Entecavir monotherapy in patients with chronic hepatitis B

Primary Outcome Measures

Name	Time	Method
serum HBsAg level	weeks 24 and 36 after adding metformin or a placebo	log IU/mL

Secondary Outcome Measures

Name	Time	Method
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
body mass index	weeks 24 and 36 after adding metformin or a placebo	kg/m\^2
HbA1c	weeks 24 and 36 after adding metformin or a placebo	percentage (%)
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

Trial Locations

Locations (1)

The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital); 🇨🇳 Tai'an, Shandong, China