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

NCT ID: NCT02554526

Last Updated: 2015-09-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Hemophilia A With Inhibitor

Study Groups

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Combination therapy

Effects of aPCC reaction in the presence of FVIII

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

Nara Medical University

OTHER

Sponsor Role lead

Responsible Party

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Keiji Nogami, MD,PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Midori Shima, MD, PhD

Role: STUDY_DIRECTOR

Nara Medical University

Locations

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Department of Pediatrics

Kashihara, Nara, Japan

Site Status

Countries

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Japan

Central Contacts

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Keiji Nogami, MD, PhD

Role: CONTACT

+81-744-29-8881

Facility Contacts

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Keiji Nogami, MD, PhD

Role: primary

+81-744-29-8881

Other Identifiers

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J150100036

Identifier Type: -

Identifier Source: org_study_id

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