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

Not Applicable

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00839202
• Lead Sponsor: Children's Hospital Los Angeles

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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The level of Factor VIII in pMols	48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Biochemistry University of Vermont; 🇺🇸 Burlington, Vermont, United States