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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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