Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yi-Kuei Chen, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01396538
First received: July 4, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in patients with serum HBV DNA can be measured, then there may be occult HBV infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had significant differences in the prevalence (2.9 ~ 22.8%) (2), but prevalence survey in Taiwan there are very few studies on this , It is hoped to be able to investigation the prevalence of occult HBV infection Among Anti-HBc Alone.


Condition
HBV Coinfection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: May 2012
Detailed Description:

The main use of this program, Taipei Medical University - Wan Fang Hospital in clinical specimens using the Roche system (Corbas e601) operating HBsAg, Anti-HBs, Anti-HBc to screen for the Anti-HBc alone group. Recycling Roche molecular system (Taq48) Real-time PCR to detect all anti-HBc alone population to understand their serum HBV-DNA viral load, in order to understand Occult HBV infection in the Anti-HBc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult HBV infection as a reference basis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

anti-HBc alone(HBsAg(-);Anti-HBs(-);Anti-HBc(+));occult HBV infection(the presence of HBV DNA in the liver and blood, in the absence Occult HBV of detectable HBsAg

Criteria

Inclusion Criteria:

HBsAg(-);Anti-HBs(-);Anti-HBc(+)

Exclusion Criteria:

None

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01396538

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Study Director: Yi-Kue Chen, college Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Yi-Kuei Chen, doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01396538     History of Changes
Other Study ID Numbers: 100028
Study First Received: July 4, 2011
Last Updated: October 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
anti-HBc alone ;occult HBV infection

Additional relevant MeSH terms:
Infection
Coinfection
Virus Diseases
Parasitic Diseases

ClinicalTrials.gov processed this record on September 22, 2014