NCT01396538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

First QC Date

July 4, 2011

Last Update Submit

October 11, 2011

Conditions

HBV Coinfection

Keywords

anti-HBc alone ；occult HBV infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan, Taiwan

Location

Study Officials

  • Yi-Kue Chen, college

    Taipei Medical University WanFang Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 4, 2011

First Posted

July 18, 2011

Study Start

June 1, 2011

Study Completion

May 1, 2012

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

TW(1)