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Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00552214
Recruitment Status : Unknown
Verified October 2007 by Novartis.
Recruitment status was:  Enrolling by invitation
First Posted : November 1, 2007
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:

Study Description
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.

Intervention/treatment
Device: Blood test

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Blood test
    Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Outcome Measures

Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 01 August 2007 to 31 December 2007 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • A positive (reactive) HIV and/or HCV and/or HBV test
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): NCT00552214


Locations
Taiwan
Taipei Blood Center Taiwan Blood Service Foundation (TBSF)
3 Fl. No. 3 Han-Hai Road, Taipei 100, Taiwan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Judith Blunt Novartis
More Information

ClinicalTrials.gov Identifier: NCT00552214     History of Changes
Other Study ID Numbers: ULT-001-TW1-Amendment 1.1
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: October 2007

Keywords provided by Novartis:
Nucleic acid test
HIV-1
hepatitis
HBV
HCV
TMA
HIV Seronegativity