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

This study has been completed.
Sponsor:
Collaborator:
University of Vermont
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00839202
First received: February 6, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hemophilia A
Device: FVIII immuno-assay
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: PK Analysis of a Novel Immunoassay in Hemophilia A

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • The level of Factor VIII in pMols [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FVIII immuno-assay Device: FVIII immuno-assay

Detailed Description:

Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional 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 concetrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839202

Locations
United States, Vermont
Department of Biochemistry University of Vermont
Burlington, Vermont, United States, 05446
Sponsors and Collaborators
Children's Hospital Los Angeles
University of Vermont
Investigators
Principal Investigator: Edward D Gomperts, MD Children's Hospital Los Angeles
Principal Investigator: Kenneth G Mann, PhD University of Vermont
  More Information

No publications provided

Responsible Party: Edward Gomperts MD, Childrens Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00839202     History of Changes
Other Study ID Numbers: CCI-06-0069-CR002
Study First Received: February 6, 2009
Last Updated: February 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
factor VIII
hemophilia A
assay

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014