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

Nanjing Medical University

Status: Unknown

Conditions: Liver Injury; Hepatitis B Virus Infection History

Treatments: Other: HBV infection history

Study type: Observational

Funder types: Other

Identifiers

NCT02808299

StatinsHBV-1

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 3 patient groups

all the antigen and antibody of HBV are negative

Description:

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

Description:

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.

Treatment:

Other: HBV infection history

HBV carriers

Description:

One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.

Treatment:

Other: HBV infection history