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

Hemophilia A Clinical Trial

Official title:

Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839202
• Other study ID #: CCI-06-0069-CR002
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: January 31, 2017
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: January 2017
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• FVIII immuno-assay
There is no intervention. This is a study of the differences in assays.

Locations

Country	Name	City	State
United States	Department of Biochemistry University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of Factor VIII in pMols		48 hours
Secondary	The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels		48 hours