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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182321
Recruitment Status : Completed
First Posted : December 2, 2019
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
Jinan Military General Hospital
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Metformin & Entecavir Drug: Placebo & Entecavir Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B: A Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date : March 13, 2020
Actual Primary Completion Date : July 2, 2021
Actual Study Completion Date : September 13, 2021


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 Name: 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 Name: Standard Therapy




Primary Outcome Measures :
  1. serum HBsAg level [ Time Frame: weeks 24 and 36 after adding metformin or a placebo ]
    log IU/mL


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182321


Locations
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China, Shandong
The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital)
Tai'an, Shandong, China, 271000
Sponsors and Collaborators
Fu-Sheng Wang
Jinan Military General Hospital
Investigators
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Study Chair: Fu-Sheng Wang The Fifth Medical Center of Chinese PLA General Hospital (Beijing 302 Hospital)
Publications:

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Responsible Party: Fu-Sheng Wang, Study Chair, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT04182321    
Other Study ID Numbers: 960-2019-84
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: After publication of the study results
Access Criteria: Researchers interested in our study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fu-Sheng Wang, Beijing 302 Hospital:
Metformin
Entecavir
chronic hepatitis B
hepatitis B virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Metformin
Entecavir
Hypoglycemic Agents
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents