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

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ClinicalTrials.gov Identifier: NCT01396538
Recruitment Status : Unknown
Verified October 2011 by Yi-Kuei Chen, Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):

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
HBV Coinfection

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
Estimated 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 : June 2011
Estimated Study Completion Date : May 2012
Groups and Cohorts


Outcome Measures

Eligibility Criteria

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
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:

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): 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

Responsible Party: Yi-Kuei Chen, doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01396538     History of Changes
Other Study ID Numbers: 100028
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Infection
Coinfection
Virus Diseases
Parasitic Diseases