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

Hemophilia A Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190149
• Other study ID #: 061302
• Status: Completed
• Start date: July 22, 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: March 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 29, 2016
• Est. primary completion date: March 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Biological:
• ADVATE (Antihemophilic Factor [Recombinant])

• RIXUBIS (Coagulation Factor IX [Recombinant])

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins University School Of Medicine	Baltimore	Maryland
United States	The Presbyterian Hospital	Charlotte	North Carolina
United States	Childrens Hospital of Michigan	Detroit	Michigan
United States	Michigan State University	East Lansing	Michigan
United States	North Shore/Long Island Jewish PRIME	Great Neck	New York
United States	The University of Texas MD Anderson	Harlingen	Texas
United States	Children's Mercy Hospitals & Clinics	Kansas City	Missouri
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center	Los Angeles	California
United States	The Vanderbilt Clinic	Nashville	Tennessee
United States	Bleeding and Clotting Disorders Institute	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Rady Childrens Hospital	San Diego	California
United States	Puget Sound Blood Center	Seattle	Washington
United States	Munson Medical Center	Traverse City	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
Secondary	Types of current physical activities of participants		Baseline through 6 months
Secondary	Activity measurement	Including: calories burned, steps taken, distance traveled, and active minutes	Baseline through 6 months
Secondary	Infusion schedule for participants on prophylaxis		Baseline through 6 months
Secondary	Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)		Baseline through 6 months
Secondary	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.	6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
Secondary	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.	Baseline and 6 months
Secondary	Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients	The PedHAL 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 participants 13-17 years of age:	Baseline and 6 months

External Links

•   To obtain more information on the study, click here/on this link.