An observational study in Hemophilia A and Hemophilia B, sponsored by Baxalta now part of Shire. Completed at 17 sites in United States. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Baxalta now part of Shire · Observational
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study
has moderately severe or severe hemophilia A or B (FVIII/FIX level
≤2%), with or without transient inhibitors
Exclusion Criteria:
Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period
Biological: ADVATE (Antihemophilic Factor [Recombinant])
Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period
Biological: RIXUBIS (Coagulation Factor IX [Recombinant])
Also known as: Octocog alfa
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.
Time frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
Types of current physical activities of participants
Time frame: Baseline through 6 months
Activity measurement
Including: calories burned, steps taken, distance traveled, and active minutes
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)
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.
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
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.
Time frame: 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:
Time frame: Baseline and 6 months
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Baxalta now part of Shire