An observational study in Hemophilia A With Inhibitor, sponsored by Nara Medical University. Status unknown at 1 site in Japan. Open to male participants. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by Nara Medical University · Observational
Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.
Comprehensive coagulation assays using recently popular rotational thromboelastometry (ROTEM), factor Xa/thrombin/plasmin generation test, and coagulation wave analysis and recently developed flow chamber system under blood flow conditions (T-TAS®) will be used. A bypassing agent, aPCC (Feiba®) and recombinant factor VIII (Advate®) will be added ex vivo to whole blood and plasma samples from patients with hemophilia A with inhibitors to compare with the coagulation effects of aPCC in the presence of factor VIII and those of aPCC in its absence under the conditions close to the physiological condition. Furthermore, the difference in the coagulation effects by the difference in inhibitor epitopes will be examined.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Nara Medical University is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
We guess that there are approximately 200-300 hemophilia A patients with inhibitors in our country. We have approximately 20 out-patients in our hospital. Based on this information, we set up the patients subjects (n=10).
Exclusion Criteria:
Effects of aPCC reaction in the presence of FVIII
Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis
Time frame: up to 10 months
Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS
Time frame: up to 15 months
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Nara Medical University