Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

Status:	Completed
Conditions:	Anemia, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	13 - 65
Updated:	10/25/2017
Start Date:	July 2014
End Date:	March 2016

This 6-month prospective outcomes study addresses the association between timing of infusion,
patient activity levels, and bleeding episodes through patient-reported measurements.

Inclusion Criteria:

- 13 to 65 years old at the time of screening

- has moderately severe or severe hemophilia A or B (FVIII/FIX level

≤2%), with or without transient inhibitors

- Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient
currently prescribed RIXUBIS (FIX)

- previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX
for ≥150 documented exposure days (EDs)

- is willing and able to comply with the requirements of the protocol

- is proficient in the English language to allow for use of the SPACE eDiary

Exclusion Criteria:

- inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor

- has participated in another clinical study involving a medicinal product or device
within 30 days prior to enrollment or is scheduled to participate in another clinical
study involving a medicinal product or device during the course of this study

- is a family member or employee of the investigator

- elective major surgery is planned within 6 months after enrollment which may interfere
with activities of daily living (at investigator's discretion)

- continuously require walking assistance devices (eg, wheelchair, crutches, etc.)

We found this trial at

sites

Presbyterian Hospital

200 Hawthorne Ln
Charlotte, North Carolina 28204

(704) 384-4000