GAS-Hem Feasibility Study

Completed

Conditions studied: Hemophilia A

In brief

The purpose of this study is to investigate the feasibility and acceptability of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in individuals with hemophilia A.

Key facts

Study ID

NCT02674997

Run by

Baxalta now part of Shire

People needed

44

Starts

2016-08-05

Expected to finish

2016-11-02

Last updated by the study team

2021-03-17

Who can join

Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has a documented diagnosis of hemophilia A
• Participant has documented clotting factor levels of 5% or less
• Participant is on a prescribed regimen of continuous prophylaxis. Continuous prophylaxis is defined by the World Federation of Hemophilia as "… the intent of treating for 52 weeks a year and receiving a minimum of an a priori defined frequency of infusions for at least 45 weeks (85%) of the year under consideration"
• Participant is willing and able to comply with the requirements of the protocol
• Participant is proficient in the English language to allow for use of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) tool.

You may not qualify if…

• Participants with an active Factor VIII (FVIII) inhibitory antibody (≥ 0.4 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time prior to screening
• Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease)
• Participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in a clinical study involving a medical product or device during the course of this study
• Participant is a family member or employee of the investigator

Where it is running

• Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States
• Oregon Health & Science University — Portland, Oregon, United States
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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