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Trial record 40 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is not yet open for participant recruitment.
Verified June 2016 by The First Affiliated Hospital with Nanjing Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02808299
First Posted: June 21, 2016
Last Update Posted: June 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University
  Purpose
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.

Condition Intervention
Liver Injury Hepatitis B Virus Infection History Other: HBV infection history

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital with Nanjing Medical University:

Primary Outcome Measures:
  • 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

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

Secondary Outcome Measures:
  • number of participants with alanine transaminase (ALT) increasing over the ULN [ Time Frame: one month, three months, six months ]

Estimated Enrollment: 600
Study Start Date: December 2016
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: HBV carriers

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808299


Contacts
Contact: Zhijian Yang, Doctor +83 13809030208 zhijianyangnj@njmu.edu.cn
Contact: Haoyu Meng, Master +86 15805167259 15805167259@163.com

Locations
China, Jiangsu
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Study Chair: Zhijian Yang, Doctor First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
  More Information

Additional Information:
Publications:

Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02808299     History of Changes
Other Study ID Numbers: StatinsHBV-1
First Submitted: June 17, 2016
First Posted: June 21, 2016
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
statin
hepatitis B virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Infection
Communicable Diseases
Wounds and Injuries
Virus Diseases
Encephalitis, Herpes Simplex
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Encephalitis, Viral
Central Nervous System Viral Diseases
Herpesviridae Infections
Infectious Encephalitis
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Antibodies
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents