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

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ClinicalTrials.gov Identifier: NCT02190149
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

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

Condition or disease Intervention/treatment
Hemophilia A Hemophilia B Biological: ADVATE (Antihemophilic Factor [Recombinant]) Biological: RIXUBIS (Coagulation Factor IX [Recombinant])

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : March 29, 2016
Actual Study Completion Date : March 29, 2016


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 Name: 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])



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Types of current physical activities of participants [ Time Frame: Baseline through 6 months ]
  2. Activity measurement [ Time Frame: Baseline through 6 months ]
    Including: calories burned, steps taken, distance traveled, and active minutes

  3. Infusion schedule for participants on prophylaxis [ Time Frame: Baseline through 6 months ]
  4. Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B) [ Time Frame: Baseline through 6 months ]
  5. 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. 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.

  7. 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:



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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190149


Locations
Show Show 17 study locations
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Study Director Takeda
Additional Information:
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02190149    
Other Study ID Numbers: 061302
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by Takeda ( Baxalta now part of Shire ):
Factor VIII Deficiency
Factor FIX Deficiency
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Factor VIII
Coagulants