Non Neutralizing Antibodies: Prevalence and Characterization
NCT ID: NCT01541527
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-02-29
2013-08-31
Brief Summary
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In a recent retrospective study the investigators evaluated, in a cohort of 210 patients without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy chain (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC, the second to display Abs directed towards the B domain. NNA were found in 38 out of 210 patients (18).
Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both chains. The proportion of NNA directed towards the B domain was 18%.
Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe HA patients, approximately 50% of severe HA patients develop an immune response against infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the routine clinical practice.
However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the variations in the kinectics of FVIII observed in certain patients.
The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not still been demonstrated.
The investigators propose to perform a multicentre prospective study with the aim to confirm, in severe, moderate and mild HA treated patietns, the NNA prevalence observed in our retrospective study, to study the evolution over time of the epitopemapping of these NNA and to explore the correlation between these NNA and clinical/biological parameters.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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severe, moderate and mild HA patients
one Arm: biological collection of 300 severe, moderate and mild HA patients
blood test
One blood test entering in the usual follow-up of the patient
Interventions
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blood test
One blood test entering in the usual follow-up of the patient
Eligibility Criteria
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Inclusion Criteria
* Severe, moderate or mild treated HA patients with negative inhibitor titer (\<0.6UB)
* An information form will be presented to the patient or his/her legal representative by the physician who includes the patient in the study protocol
* Patient with national insurance
Exclusion Criteria
* Patient deprived of freedom
* Patient without national insurance
6 Years
MALE
No
Sponsors
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Hôpital de la Timone
OTHER
University Hospital, Clermont-Ferrand
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
University Hospital, Toulouse
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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CHU de Montpellier- Centre administratif André Benech
Montpellier, , France
Countries
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References
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Lavigne-Lissalde G, Rothschild C, Pouplard C, Lapalud P, Gruel Y, Schved JF, Granier C. Characteristics, mechanisms of action, and epitope mapping of anti-factor VIII antibodies. Clin Rev Allergy Immunol. 2009 Oct;37(2):67-79. doi: 10.1007/s12016-009-8119-0.
Lavigne-Lissalde G, Tarrade C, Lapalud P, Chtourou S, Schved JF, Granier C, Villard-Saussine S. Simultaneous detection and epitope mapping of anti-factor VIII antibodies. Thromb Haemost. 2008 Jun;99(6):1090-6. doi: 10.1160/TH07-08-0497.
Lavigne-Lissalde G, Lacroix-Desmazes S, Wootla B, Tarrade C, Schved JF, Kaveri SV, Granier C, Villard-Saussine S. Molecular characterization of human B domain-specific anti-factor VIII monoclonal antibodies generated in transgenic mice. Thromb Haemost. 2007 Jul;98(1):138-47.
Other Identifiers
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UF 8844
Identifier Type: -
Identifier Source: org_study_id