Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment
Status: | Completed |
---|---|
Conditions: | Anemia, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 3/29/2019 |
Start Date: | December 9, 2015 |
End Date: | March 26, 2018 |
A Prospective, International, Longitudinal, Observational Disease Registry of Patient-reported Outcomes (PROs) and the Association With Hemophilia A and Its Treatment in Patients With Moderate to Severe Hemophilia A
The purpose of the study is to improve the understanding of key patient reported outcomes
such as quality of life as well as clinical outcomes in hemophilia A, in a global real world
setting.
such as quality of life as well as clinical outcomes in hemophilia A, in a global real world
setting.
Inclusion Criteria:
- Age 16 or over.
- Have documentation of physician-confirmed diagnosis of moderate or severe Hemophilia A
(severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity
≤1%).
- Signed written informed consent provided by the patient or the patient's parents for
patients under the age of 18 (dependent of local regulations).
- Signed written assent is also required for patients under the age 18 years (dependent
on local regulations).
- Plan to receive at least half of their Hemophilia care at the registry site.
- Willing and able to enter data as per the data collection schedule.
- Currently receiving prophylactic or on demand treatment (including within last 6months
for on demand).
- Expected life expectancy of at least 2 years.
Exclusion Criteria:
- Patients with Hemophilia B
- Patients with von Willebrand disease (vWD)
- Patients with other rare bleeding disorders
- Unable to comply with the study protocol
We found this trial at
8
sites
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