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NCT02808299 Clinical Trial

Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection

Liver Injury Clinical Trial

— LISHBV  

Official title:
Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02808299
Other study ID # StatinsHBV-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 17, 2016
Last updated June 17, 2016
Start date December 2016

Study information
Verified date June 2016
Source The First Affiliated Hospital with Nanjing Medical University
Contact Zhijian Yang, Doctor
Phone +83 13809030208
Email zhijianyangnj@njmu.edu.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• HBV infection history
HBV infection history or HBV carriers

Locations
Country Name City State
China First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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: 2008/29/smw-12311. Review. — View 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. Review. — View 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. Epub 2006 Feb 3. — View Citation

Ekstedt M, Franzén 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. Epub 2007 Mar 8. — View 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. — View 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. — View Citation

Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary changes of alanine transaminase (ALT, U/L) The peak increases of ALT from baseline to follow-up one month, three months, six months Yes
Primary number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN) one month, three months, six months Yes
Secondary number of participants with alanine transaminase (ALT) increasing over the ULN one month, three months, six months Yes
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