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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00552214
• Collaborator: (none)
• Enrollment: 10,290
• Location: 1
• Arm: 1
• Duration (Months): 10.8
• Patients Per Site Per Month: 954.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations	Device: Blood test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10290 participants
• Allocation: N/A
• 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: Aug 8, 2007
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Human Blood Donor Plasma Specimens	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 [01 August 2007 to 31 December 2007]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Taipei Blood Center Taiwan Blood Service Foundation (TBSF)	Taipei		Taiwan	100

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Study Director, Grifols Biologicals, LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Novartis results database

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00552214
• Other Study ID Numbers: ULT-001-TW1-Amendment 1.1
• First Posted: Nov 1, 2007
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Novartis: Nucleic acid test; HIV-1; hepatitis; HBV; HCV; TMA; HIV Seronegativity

Study Results

No Results Posted as of Feb 21, 2021