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

June 17, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all the antigen and antibody of HBV are negative
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
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.
Other: HBV infection history
HBV infection history or HBV carriers
Other Names:
  • HBV carriers
HBV carriers
One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.
Other: HBV infection history
HBV infection history or HBV carriers
Other Names:
  • HBV carriers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month, three months, six months
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
Time Frame: one month, three months, six months
one month, three months, six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Zhijian Yang, Doctor, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StatinsHBV-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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