Procleix® Dengue Virus Assay Testing of Individual Donor... | NCT01656174

Studies
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

NCT01656174

Sponsor

Gen-Probe, Incorporated

Status

Completed

Last Update Posted

Mar 20, 2015Estimated

Enrollment

35,035Actual

Phase

Not provided

Conditions

Dengue

Interventions

Procleix Dengue Virus Assay

Countries

United States

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

Mar 2015

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 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jul 31, 2012

First Submission Date that Met QC Criteria

Jul 31, 2012

First Posted Date

Aug 2, 2012Estimated

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

Mar 19, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35,035Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Treatment			Device: Procleix Dengue Virus Assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Procleix Dengue Virus Assay	Device	in vitro diagnostic assay	No Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.		Approximately three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Donor must meet all the blood collection sites' standard eligibility requirements.
Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

volunteer blood donors from Puerto Rico

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renee Wait	Gen-Probe, Incorporated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creative Testing Solutions		Tempe	Arizona	85282	United States
American Red Cross National Testing Laboratory

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided