Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
NCT ID: NCT02808299
Last Updated: 2016-06-21
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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UNKNOWN
600 participants
OBSERVATIONAL
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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all the antigen and antibody of HBV are negative
Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative.
No interventions assigned to this group
HBV infection history
One or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded.
HBV infection history
HBV infection history or HBV carriers
HBV carriers
One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.
HBV infection history
HBV infection history or HBV carriers
Interventions
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HBV infection history
HBV infection history or HBV carriers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
* triglyceride is over 4.5 mmol/L
* decompensated liver cirrhosis (Child B or C)
* active stage of HBV
* infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease
* congestive heart failure
* malignant tumor
* autoimmune disease
* receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Zhijian Yang, Doctor
Role: STUDY_CHAIR
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Locations
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First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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References
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Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f.
Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8.
Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845.
Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311.
Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.
Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.
Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.
Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available.
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Other Identifiers
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StatinsHBV-1
Identifier Type: -
Identifier Source: org_study_id
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