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

N

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

Trial contacts and locations

1

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Central trial contact

Haoyu Meng, Master; Zhijian Yang, Doctor

Data sourced from clinicaltrials.gov

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