Clinical Performance Evaluation of DxN CMV Assay | NCT03127787

Studies
Clinical Performance Evaluation of DxN CMV Assay

NCT03127787

Sponsor

Beckman Coulter, Inc.

Status

Terminated

Last Update Posted

Jul 12, 2018Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Cytomegalovirus

Interventions

CMV 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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Aug 30, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Apr 17, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 25, 2017Actual

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

Jul 10, 2018

Last Update Posted Date

Jul 12, 2018Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

Detailed Description

same as brief summary

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CMV infected		CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care.	Diagnostic Test: CMV Assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CMV Assay	Diagnostic Test	Molecular diagnostic test to detect CMV	CMV infected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
virological response to therapy	Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years old
Must have had a kidney transplant and be evaluated for post-transplantation care
Must have demonstrated post-transplant CMV DNAemia
Must be eligible for and treated with anti-CMV drugs

Exclusion Criteria:

HIV positive
Proven ganciclovir or valganciclovir resistance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult kidney transplant recipients undergoing CMV therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California		United States
NWU

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