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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COMPLETED
EARLY_PHASE1
12 participants
INTERVENTIONAL
2022-08-01
2024-07-14
Brief Summary
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Detailed Description
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The investigators will study the hemostatic effect using Thrombin Generation assay (CAT) in the presence of different concentrations of FIX concentrates. The investigators will compare the hemostatic effect of added FIX to the effect of added bypassing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII)
Plasma will be collected from patients with hemophilia A and inhibitors treated with Emicizumab, a group of plasma samples will be spiked with different concentrations of Factor IX. Thrombin generation profiles will be obtained using CAT.
Another group of plasma samples will be spiked with different concentrations of by passing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII). Thrombin generation profiles will be obtained using CAT.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Patient Group
In vitro spiking experiments will be realized in plasmas from patients with severe haemophilia A on emicizumab using increasing concentrations of factor IX (rFIX), Activated prothrombin complex (aPCC) and recombinant VIIa (rFVIIa).
Factor IX
Factor IX is on of the substrates of emicizumab.
Interventions
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Factor IX
Factor IX is on of the substrates of emicizumab.
Eligibility Criteria
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Inclusion Criteria
* Male patients, Age 12 years and older at time of signing Informed Consent Form
* Ability to comply with the study protocol, in the investigator's judgment
* Diagnosis of severe hemophilia A and are receiving emicizumab prophylaxis, on a weekly maintenance regimen
Exclusion Criteria
* Not willing to provide extra blood for the experiments.
* Patients carrying the diagnoses of other coagulopathies in addition to hemophilia A
* Patients that have received any hemostatic agent within 5 half-lives of the blood draw. This applies to any agent that might have been used for any reason prior to the blood draw and might affect the global hemostasis.
12 Years
120 Years
MALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Tulane University
OTHER
Responsible Party
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Principal Investigators
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Maissa Janbain, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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Tulane University Lakeside Hospital and Clinics
Metairie, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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2022-200
Identifier Type: -
Identifier Source: org_study_id
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