NCT00552214

Brief Summary

The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

October 30, 2007

Last Update Submit

February 17, 2021

Conditions

Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Keywords

Nucleic acid testHIV-1hepatitisHBVHCVTMAHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

    01 August 2007 to 31 December 2007

Study Arms (1)

Human Blood Donor Plasma Specimens

OTHER
Device: Blood test

Interventions

Blood testDEVICE

Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Human Blood Donor Plasma Specimens

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

You may not qualify if:

  • A positive (reactive) HIV and/or HCV and/or HBV test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Blood Center Taiwan Blood Service Foundation (TBSF)

Taipei, 100, Taiwan

Location

Related Links

MeSH Terms

Conditions

Hepatitis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Study Director

    Grifols Biologicals, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2007

First Posted

November 1, 2007

Study Start

August 8, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)