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

Hemophilia A With Inhibitor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02554526
• Other study ID #: J150100036
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 17, 2015
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Nara Medical University
• Contact: Keiji Nogami, MD, PhD
• Phone: +81-744-29-8881
• Email: roc-noga[@]naramed-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A With Inhibitor

Locations

Country	Name	City	State
Japan	Department of Pediatrics	Kashihara	Nara

Sponsors (2)

Lead Sponsor	Collaborator
Nara Medical University	Baxalta US Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis		up to 10 months	No
Primary	Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS		up to 15 months	No