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NCT Number: NCT04182321

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital)

Tai’an, Shandong, 271000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin & Entecavir

Drug

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 & Entecavir

Drug

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

Primary outcomes

  1. serum HBsAg level

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    log IU/mL

Secondary outcomes

  1. weight

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    kg

  2. body mass index

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    kg/m^2

  3. fasting glucose

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    mmol/L

  4. HbA1c

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    percentage (%)

  5. triglycerides

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    mmol/L

  6. total cholesterol

    Time frame: weeks 24 and 36 after adding metformin or a placebo

    mmol/L

Sponsors and collaborators

Lead sponsor

Fu-Sheng Wang

Other

Collaborators

  • Jinan Military General Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2019
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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