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

March 16, 2021 updated by: Baxalta now part of Shire
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center
      • San Diego, California, United States, 92123
        • Rady Childrens Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Bleeding and Clotting Disorders Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Childrens Hospital of Michigan
      • East Lansing, Michigan, United States, 48823
        • Michigan State University
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • CHILDREN'S MERCY HOSPITALS & CLINICS
    • New York
      • Great Neck, New York, United States, 11021
        • North Shore/Long Island Jewish PRIME
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • The Presbyterian Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • The Vanderbilt Clinic
    • Texas
      • Harlingen, Texas, United States, 78550
        • The University of Texas MD Anderson
    • Washington
      • Seattle, Washington, United States, 98104
        • Puget Sound Blood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ADVATE (Factor VIII)
Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period
Biological: ADVATE (Antihemophilic Factor [Recombinant])
Other Names:
  • Octocog alfa
RIXUBIS (Factor IX)
Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period
Biological: RIXUBIS (Coagulation Factor IX [Recombinant])

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs)
Time Frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of current physical activities of participants
Time Frame: Baseline through 6 months
Baseline through 6 months
Activity measurement
Time Frame: Baseline through 6 months
Including: calories burned, steps taken, distance traveled, and active minutes
Baseline through 6 months
Infusion schedule for participants on prophylaxis
Time Frame: Baseline through 6 months
Baseline through 6 months
Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)
Time Frame: Baseline through 6 months
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
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
Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients
Time Frame: Baseline and 6 months
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
Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients
Time Frame: Baseline and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2014

Primary Completion (Actual)

March 29, 2016

Study Completion (Actual)

March 29, 2016

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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