Hemophilia A
Conditions
Keywords
factor VIII, hemophilia A, assay
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.
Interventions
OTHERFVIII immuno-assay
There is no intervention. This is a study of the differences in assays.
Sponsors
University of Vermont
Children's Hospital Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of Factor VIII in pMols | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels | 48 hours |
Countries
United States
Outcome results
None listed