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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: The First Affiliated Hospital with Nanjing Medical University

Current Primary Outcome:

  • changes of alanine transaminase (ALT, U/L) [ Time Frame: one month, three months, six months ]
    The peak increases of ALT from baseline to follow-up
  • number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN) [ Time Frame: one month, three months, six months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: number of participants with alanine transaminase (ALT) increasing over the ULN [ Time Frame: one month, three months, six months ]

Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital with Nanjing Medical University

Dates:
Date Received: June 17, 2016
Date Started: December 2016
Date Completion:
Last Updated: June 17, 2016
Last Verified: June 2016