Hemophilia ASPACENCT02190149
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
An observational study of Hemophilia A and Hemophilia B, run by Baxalta now part of Shire at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- ADVATE (Antihemophilic Factor [Recombinant]) and RIXUBIS (Coagulation Factor IX [Recombinant])
- How many people
- 64 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Jul 2014to 29 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205
The Presbyterian Hospital
Charlotte, North Carolina, 28210
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Michigan State University
East Lansing, Michigan, 48823
North Shore/Long Island Jewish PRIME
Great Neck, New York, 11021
The University of Texas MD Anderson
Harlingen, Texas, 78550
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108
University of Kentucky Medical Center
Lexington, Kentucky, 40504
Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center
Los Angeles, California, 90007
The Vanderbilt Clinic
Nashville, Tennessee, 37232
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61615
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Rady Childrens Hospital
San Diego, California, 92123
Puget Sound Blood Center
Seattle, Washington, 98104
Munson Medical Center
Traverse City, Michigan, 49684
About this study
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- ADVATE (Antihemophilic Factor [Recombinant]), RIXUBIS (Coagulation Factor IX [Recombinant])
- Keywords
- Factor VIII Deficiency, Factor FIX Deficiency
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVATE (Antihemophilic Factor [Recombinant])Biological
Also called Octocog alfa
RIXUBIS (Coagulation Factor IX [Recombinant])Biological
| Study group | Role | What they receive |
|---|---|---|
| ADVATE (Factor VIII) | Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period Receives: Biological: ADVATE (Antihemophilic Factor [Recombinant]) | |
| RIXUBIS (Factor IX) | Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period Receives: Biological: RIXUBIS (Coagulation Factor IX [Recombinant]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
Secondary outcomes (7)
Types of current physical activities of participants
Measured: Baseline through 6 months
Activity measurement
Including: calories burned, steps taken, distance traveled, and active minutes
Measured: Baseline through 6 months
Infusion schedule for participants on prophylaxis
Measured: Baseline through 6 months
Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)
Measured: Baseline through 6 months
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.
Measured: 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
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.
Measured: Baseline and 6 months
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:
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study start22 Jul 2014
- Primary completion29 Mar 2016
- Study completion29 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190149
- Sponsor's protocol ID
- 061302
- Acronym
- SPACE
- Status last verified
- Mar 2021
- First submitted
- 14 Jul 2014
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
- ClinicalTrials.gov ID
- NCT02190149
- Acronym / sponsor ID
- SPACE / 061302
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Factor VIII Deficiency, Factor FIX Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 29 Mar 2016 (actual)
- Study completion
- 29 Mar 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADVATE (Factor VIII) | – | Biological: ADVATE (Antihemophilic Factor [Recombinant])Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period |
| RIXUBIS (Factor IX) | – | Biological: RIXUBIS (Coagulation Factor IX [Recombinant])Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADVATE (Antihemophilic Factor [Recombinant])Also: Octocog alfa | Biological | ADVATE (Factor VIII) |
| RIXUBIS (Coagulation Factor IX [Recombinant]) | Biological | RIXUBIS (Factor IX) |
Primary outcome
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.
7 secondary outcomes
Types of current physical activities of participants
Time frame: Baseline through 6 months
Activity measurement
Time frame: Baseline through 6 months
Infusion schedule for participants on prophylaxis
Time frame: Baseline through 6 months
Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)
Time frame: 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
Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients
Time frame: Baseline and 6 months
Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Baxalta now part of Shire at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.