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

N/ACompletedNCT02190149

Baxalta now part of Shire64 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hemophilia A Hemophilia B

Interventions

ADVATE (Antihemophilic Factor [Recombinant])BIOLOGICAL

RIXUBIS (Coagulation Factor IX [Recombinant])BIOLOGICAL

Eligibility

Sex: ALLMin age: 13 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.)

Locations (17)

Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center

Los Angeles, California, United States

Rady Childrens Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs)

After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.

Time frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months

Secondary Outcomes

Types of current physical activities of participants

Time frame: Baseline through 6 months

Activity measurement

Including: calories burned, steps taken, distance traveled, and active minutes

Time frame: Baseline through 6 months

Infusion schedule for participants on prophylaxis

Time frame: Baseline through 6 months

Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)

Time frame: Baseline through 6 months

Occurrence of bleeding episodes (BEs)

Time frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months

Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients

The HAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for adults.

Data from ClinicalTrials.gov

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