Hepatitis B Virus Infection History, Liver Injury
Conditions
Keywords
statin, hepatitis B virus
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.
Interventions
OTHERHBV infection history
HBV infection history or HBV carriers
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| number of participants with alanine transaminase (ALT) increasing over the ULN | one month, three months, six months |
Countries
China
Contacts
Primary ContactZhijian Yang, Doctor
Backup ContactHaoyu Meng, Master
Outcome results
None listed