Hemophilia A
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Patients who have completed IMP administration in the ACE001JP study who also meet either of the following criteria 1) Patient with inhibitors 2) Patient without inhibitors who has experienced at least three bleeding episodes in the six months prior to enrollment in the ACE001JP study (2) Patient who has been judged elidgible to enroll in this study by the Efficacy and Safety Evaluation Committee.
Exclusion criteria
Exclusion criteria: (1) Patient who has been withdrawn from observation in the ACE001JP study because of an adverse event for which a causal relationship cannot be ruled out. (2) Bleeding disorder other than congenital hemophilia A (3) Previous or concomitant thromboembolic disease such as deep vein thrombosis, or signs of thromboembolic disease (4) Planned immune tolerance induction therapy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Observation and Laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics pharmacodynamics Laboratory tests | — |
Countries
Japan
Outcome results
None listed