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

• Conditions: Hepatitis B Virus Infection History; Liver Injury
• Interventions: Other: HBV infection history

• Registration Number: NCT02808299
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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 Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-21
• Last Update Posted: 2016-06-21
• Study Start: 2016-12
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBV infection history	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	HBV infection history	One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.

Primary Outcome Measures

Name	Time	Method
changes of alanine transaminase (ALT, U/L)	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)	one month, three months, six months

Secondary Outcome Measures

Name	Time	Method
number of participants with alanine transaminase (ALT) increasing over the ULN	one month, three months, six months

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China