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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02554526
• Date of registration: 15/09/2015
• Prospective Registration: No
• Primary sponsor: Nara Medical University
• Public title: Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors
• Scientific title: Basic Study on Novel Therapeutic Strategy With Bypassing Agent Therapy in Hemophilia A Patients With Inhibitors
• Date of first enrolment: September 2015
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02554526
• Study type: Observational
• Study design: N/A
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Keiji Nogami, MD, PhD

• Name: Keiji Nogami, MD, PhD

• Name: Midori Shima, MD, PhD
• Affiliation: Nara Medical University

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Hemophilia A With Inhibitor

Primary Outcome(s)

Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS [Time Frame: up to 15 months]

Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis [Time Frame: up to 10 months]

Secondary ID(s)

J150100036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Baxalta US Inc.