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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00552214
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007

October 30, 2007
November 5, 2007
August 2007
Not Provided
Sensitivity and Specificity [ Time Frame: 01 August 2007 to 31 December 2007 ]
Same as current
Complete list of historical versions of study NCT00552214 on ClinicalTrials.gov Archive Site
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Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

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.

Not Provided
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Not Provided
Device: Blood test
Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10500
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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
Both
17 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00552214
ULT-001-TW1-Amendment 1.1
Not Provided
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Novartis
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Study Director: Judith Blunt Novartis
Novartis
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP