Back to resultsActivity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
Primary Purpose
Hemophilia A
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FVIII immuno-assay
Sponsored by
About this trial
This is an interventional basic science trial for Hemophilia A focused on measuring factor VIII, hemophilia A, assay
Eligibility 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
Sites / Locations
- Department of Biochemistry University of Vermont
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FVIII immuno-assay
Arm Description
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.
Outcomes
Primary Outcome Measures
The level of Factor VIII in pMols
Secondary Outcome Measures
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Full Information
NCT ID
NCT00839202
First Posted
February 6, 2009
Last Updated
January 31, 2017
Sponsor
Children's Hospital Los Angeles
Collaborators
University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT00839202
Brief Title
Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
Official Title
Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
University of Vermont
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
factor VIII, hemophilia A, assay
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FVIII immuno-assay
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FVIII immuno-assay
Intervention Description
There is no intervention. This is a study of the differences in assays.
Primary Outcome Measure Information:
Title
The level of Factor VIII in pMols
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Time Frame
48 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward D Gomperts, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth G Mann, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biochemistry University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
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