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

Baxalta

Status: Completed

Conditions: Hemophilia B; Hemophilia A

Treatments: Biological: RIXUBIS (Coagulation Factor IX [Recombinant]); Biological: ADVATE (Antihemophilic Factor [Recombinant])

Study type: Observational

Funder types: Industry

Identifiers

NCT02190149

061302

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

64 participants in 2 patient groups

ADVATE (Factor VIII)

Description:

Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period

Treatment:

Biological: ADVATE (Antihemophilic Factor [Recombinant])

RIXUBIS (Factor IX)

Description:

Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period

Treatment:

Biological: RIXUBIS (Coagulation Factor IX [Recombinant])