Clinical trial NCT02808299: Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
Official title: Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Injury
Hepatitis B Virus Infection History
Keywords: statin
hepatitis B virus
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.

Brief summary: The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.


Eligibility criteria: Inclusion Criteria:

* patients with CHD receive long-term statin treatment

Exclusion Criteria:

* ALT is over ULN at baseline
* 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.

Primary outcomes:
measure: changes of alanine transaminase (ALT, U/L)
timeFrame: one month, three months, six months
measure: number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
timeFrame: one month, three months, six months
Secondary outcomes:
measure: number of participants with alanine transaminase (ALT) increasing over the ULN
timeFrame: one month, three months, six months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
name: Zhijian Yang, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.