Evaluation of HIV-1, HCV and HBV Blood Screening Tests Wi... | NCT00552214

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

NCT00552214

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

10,290Actual

Phase

Not Applicable

Conditions

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

Interventions

Blood test

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2007

Primary Completion Date

Jul 1, 2008Actual

Completion Date

Jul 1, 2008Actual

First Submitted Date

Oct 30, 2007

First Submission Date that Met QC Criteria

Oct 30, 2007

First Posted Date

Nov 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 21, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human Blood Donor Plasma Specimens	Other		Device: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Device	Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens	Human Blood Donor Plasma Specimens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity		01 August 2007 to 31 December 2007

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Grifols Biologicals, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Blood Center Taiwan Blood Service Foundation (TBSF)		Taipei		100	Taiwan

Label	URL
Novartis results database	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006505	Hepatitis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided