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Completed

NCT Number: NCT00839202

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry University of Vermont

Burlington, Vermont, 05446, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FVIII immuno-assay

Other

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

Primary outcomes

  1. The level of Factor VIII in pMols

    Time frame: 48 hours

Secondary outcomes

  1. The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • University of Vermont

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Feb 9, 2009
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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