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Completed

NCT Number: NCT02190149

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

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

ADVATE (Antihemophilic Factor [Recombinant])

Biological

Other names: Octocog alfa

RIXUBIS (Coagulation Factor IX [Recombinant])

Biological

Primary outcomes

  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 outcomes

  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:

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Acronym: SPACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2014
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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