Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
LISHBV
Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedJune 21, 2016
June 1, 2016
4 years
June 17, 2016
June 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
changes of alanine transaminase (ALT, U/L)
The peak increases of ALT from baseline to follow-up
one month, three months, six months
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
one month, three months, six months
Secondary Outcomes (1)
number of participants with alanine transaminase (ALT) increasing over the ULN
one month, three months, six months
Study Arms (3)
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.
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 carriers
One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.
Interventions
HBV infection history or HBV carriers
Eligibility Criteria
Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.
You may qualify if:
- patients with CHD receive long-term statin treatment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Related Publications (8)
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.
PMID: 15198967BACKGROUNDEkstedt 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.
PMID: 17400325BACKGROUNDSegarra-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.
PMID: 17542767BACKGROUNDBalmer 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.
PMID: 18654866BACKGROUNDCohen 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.
PMID: 16581333BACKGROUNDWatkins 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.
PMID: 16496329BACKGROUNDLu 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.
PMID: 20041146BACKGROUNDZhang 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.
PMID: 21129795RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhijian Yang, Doctor
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 21, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2020
Last Updated
June 21, 2016
Record last verified: 2016-06