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

NCT ID: NCT00839202

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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FVIII immuno-assay

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.

Group Type EXPERIMENTAL

FVIII immuno-assay

Intervention Type OTHER

There is no intervention. This is a study of the differences in assays.

Interventions

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FVIII immuno-assay

There is no intervention. This is a study of the differences in assays.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Vermont

OTHER

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Edward Gomperts

Attending Hematologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward D Gomperts, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Kenneth G Mann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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Department of Biochemistry University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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CCI-06-0069-CR002

Identifier Type: -

Identifier Source: org_study_id

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