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

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01396538
Collaborator
(none)
200
Enrollment
1
Location
11
Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan
    Study Start Date :
    Jun 1, 2011
    Anticipated Study Completion Date :
    May 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

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

      Exclusion Criteria:

      None

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Yi-Kuei Chen, doctor, Taipei Medical University WanFang Hospital
      ClinicalTrials.gov Identifier:
      NCT01396538
      Other Study ID Numbers:
      • 100028
      First Posted:
      Jul 18, 2011
      Last Update Posted:
      Oct 12, 2011
      Last Verified:
      Oct 1, 2011
      Keywords provided by Yi-Kuei Chen, doctor, Taipei Medical University WanFang Hospital
      anti-HBc alone ；occult HBV infection
      Additional relevant MeSH terms:
      Infections
      Coinfection

      Study Results

      No Results Posted as of Oct 12, 2011