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

November 23, 2021 updated by: Fu-Sheng Wang

Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Tai'an, Shandong, China, 271000
        • The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy
Metformin as add-on to entecavir therapy in patients with chronic hepatitis B
Drug: Metformin & 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)
Other Names:
  • Combination Therapy
Placebo Comparator: Standard Therapy
Entecavir monotherapy in patients with chronic hepatitis B
Drug: Placebo & Entecavir
Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)
Other Names:
  • Standard Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum HBsAg level
Time Frame: weeks 24 and 36 after adding metformin or a placebo
log IU/mL
weeks 24 and 36 after adding metformin or a placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: weeks 24 and 36 after adding metformin or a placebo
kg
weeks 24 and 36 after adding metformin or a placebo
body mass index
Time Frame: weeks 24 and 36 after adding metformin or a placebo
kg/m^2
weeks 24 and 36 after adding metformin or a placebo
fasting glucose
Time Frame: weeks 24 and 36 after adding metformin or a placebo
mmol/L
weeks 24 and 36 after adding metformin or a placebo
HbA1c
Time Frame: weeks 24 and 36 after adding metformin or a placebo
percentage (%)
weeks 24 and 36 after adding metformin or a placebo
triglycerides
Time Frame: weeks 24 and 36 after adding metformin or a placebo
mmol/L
weeks 24 and 36 after adding metformin or a placebo
total cholesterol
Time Frame: weeks 24 and 36 after adding metformin or a placebo
mmol/L
weeks 24 and 36 after adding metformin or a placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu-Sheng Wang

Collaborators

Jinan Military General Hospital

Investigators

  • Study Chair: Fu-Sheng Wang, The Fifth Medical Center of Chinese PLA General Hospital (Beijing 302 Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Actual)

July 2, 2021

Study Completion (Actual)

September 13, 2021

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960-2019-84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified individual participant data and full study protocol are available upon reasonable request. Researchers should send it to fswang302@163.com to gain access.

IPD Sharing Time Frame

After publication of the study results

IPD Sharing Access Criteria

Researchers interested in our study

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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