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

Oregon Health and Science University

3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239

503 494-8311