Trial record 42 of 511 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2016 by The First Affiliated Hospital with Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT02808299
First received: June 17, 2016
Last updated: NA
Last verified: June 2016
History: No changes posted
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 17, 2016
Last Updated: June 17, 2016
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis B
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Wounds and Injuries
Infection
Communicable Diseases
Virus Diseases
Encephalitis, Herpes Simplex
Hepadnaviridae Infections
DNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA 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
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016