Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B
NCT ID: NCT04182321
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-03-13
2021-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combination Therapy
Metformin as add-on to entecavir therapy in patients with chronic hepatitis B
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)
Standard Therapy
Entecavir monotherapy in patients with chronic hepatitis B
Placebo & Entecavir
Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)
Interventions
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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)
Placebo & Entecavir
Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Jinan Military General Hospital
OTHER
Fu-Sheng Wang
OTHER
Responsible Party
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Fu-Sheng Wang
Study Chair
Principal Investigators
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Fu-Sheng Wang
Role: STUDY_CHAIR
The Fifth Medical Center of Chinese PLA General Hospital (Beijing 302 Hospital)
Locations
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The 960th Hospital of Chinese PLA Joint Logistics Support Force (Jinan Military General Hospital)
Tai’an, Shandong, China
Countries
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References
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Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27.
GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1736-1788. doi: 10.1016/S0140-6736(18)32203-7. Epub 2018 Nov 8.
Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
Xun YH, Zhang YJ, Pan QC, Mao RC, Qin YL, Liu HY, Zhang YM, Yu YS, Tang ZH, Lu MJ, Zang GQ, Zhang JM. Metformin inhibits hepatitis B virus protein production and replication in human hepatoma cells. J Viral Hepat. 2014 Aug;21(8):597-603. doi: 10.1111/jvh.12187. Epub 2013 Oct 24.
Honda M, Shirasaki T, Terashima T, Kawaguchi K, Nakamura M, Oishi N, Wang X, Shimakami T, Okada H, Arai K, Yamashita T, Sakai Y, Yamashita T, Mizukoshi E, Kaneko S. Hepatitis B Virus (HBV) Core-Related Antigen During Nucleos(t)ide Analog Therapy Is Related to Intra-hepatic HBV Replication and Development of Hepatocellular Carcinoma. J Infect Dis. 2016 Apr 1;213(7):1096-106. doi: 10.1093/infdis/jiv572. Epub 2015 Nov 29.
Other Identifiers
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960-2019-84
Identifier Type: -
Identifier Source: org_study_id
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