Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 6, 2009
CompletedFirst Posted
Study publicly available on registry
February 9, 2009
CompletedFebruary 1, 2017
January 1, 2017
2 years
February 6, 2009
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The level of Factor VIII in pMols
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
48 hours
Study Arms (1)
FVIII immuno-assay
EXPERIMENTALThe 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.
Interventions
There is no intervention. This is a study of the differences in assays.
Eligibility Criteria
You may qualify if:
- adults with hemophilia A
- factor VIII less that 2%
- informed consent signed
- absence of an inhibitor
You may not qualify if:
- history of a high responding inhibitor anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Los Angeleslead
- University of Vermontcollaborator
Study Sites (1)
Department of Biochemistry University of Vermont
Burlington, Vermont, 05446, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward D Gomperts, MD
Children's Hospital Los Angeles
- PRINCIPAL INVESTIGATOR
Kenneth G Mann, PhD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Hematologist
Study Record Dates
First Submitted
February 6, 2009
First Posted
February 9, 2009
Study Start
September 1, 2006
Primary Completion
September 1, 2008
Study Completion
February 1, 2009
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share