Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors

Basic Study on Novel Therapeutic Strategy With Bypassing Agent Therapy in Hemophilia A Patients With Inhibitors

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02554526

Enrollment

Registered

2015-09-18

Start date

2015-09-30

Completion date

2017-12-31

Last updated

2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A With Inhibitor

Keywords

hemophilia A, inhibitor, bypassing therapy, factor VIII

Brief summary

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.

Detailed description

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.

Interventions

None listed

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Patients with hemophilia A with inhibitors (Inhibitor titer; \>0.5 Bethesda U/ml) * Patients with agreement consents with the patients signatures

Exclusion criteria

* Patients that do not fill the conditions described above

Design outcomes

Primary

Measure	Time frame
Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis	up to 10 months
Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS	up to 15 months

Countries

Japan

Contacts

Primary ContactKeiji Nogami, MD, PhD

roc-noga@naramed-u.ac.jp+81-744-29-8881

Outcome results