Activity and Content of Factor VIII (FVIII) in Human Plas... | NCT00839202

Studies
Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay

NCT00839202

Sponsor

Children's Hospital Los Angeles

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Hemophilia A

Interventions

FVIII immuno-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

Jan 2017

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

Sep 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Feb 6, 2009

First Submission Date that Met QC Criteria

Feb 6, 2009

First Posted Date

Feb 9, 2009Estimated

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

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Name	Class
University of Vermont	OTHER

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

A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.

Detailed Description

Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FVIII immuno-assay	Experimental	The study is not designed as a therapeutic evaluation, but an assessment of clotting factor VIII timed responses after the infusion of specified doses of licensed clotting factor VIII concentrates. The purpose of the study is to measure the levels of infused licensed clotting factor VIII by standard assay techniques and comparing these standard assays with an experimental assay. Measurements of possible co-factors that might impact the results were also carried out.	Other: FVIII immuno-assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FVIII immuno-assay	Other	There is no intervention. This is a study of the differences in assays.	FVIII immuno-assay

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The level of Factor VIII in pMols		48 hours

Secondary Outcomes

Measure	Description	Time Frame
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels		48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults with hemophilia A
factor VIII less that 2%
informed consent signed
absence of an inhibitor

Exclusion Criteria:

history of a high responding inhibitor anemia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward D Gomperts, MD	Children's Hospital Los Angeles	Principal Investigator
Kenneth G Mann, PhD	University of Vermont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Biochemistry University of Vermont		Burlington	Vermont	05446	United States

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
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided