Hemophilia A
Conditions
Interventions
investigational material(s)
Generic name etc : ELOCTATE
INN of investigational material : -
Therapeutic category code : 634 Human blood preparations
Dosage and Administration for Investigational mate
Sponsors
Sanofi K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hemophilia A with any severity and treated with rFVIIIFc Detailed criteria are described in the protocol. Patients less than 18 years of age with hemophilia A with any severity and treated with rFVIIIFc. (include over 18 years patients in part 2 study) Part 1 study: general pediatric study Part 2 study: inhibitor positive patient diagnosed by the treating physician
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist. 1.Patients to whom Informed consent cannot be conducted or who have no willingness to provide informed consent 2.Those with other bleeding disorder than hemophilia A 3.Patients 18 years of age and older at entry (part 1 study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Annual spontanious bleeding rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory other Inhibitor incidence Total infusion number per year Total dosage per year SAE and ADR | — |
Countries
Japan
Outcome results
None listed