An interventional study of FVIII immuno-assay in Hemophilia A, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Basic science
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.
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 7 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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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
There is no intervention. This is a study of the differences in assays.
The level of Factor VIII in pMols
Time frame: 48 hours
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Time frame: 48 hours
Plan to share: No
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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Children's Hospital Los Angeles