Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment

Completed

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT02396862

Run by

Bayer

People needed

272

Starts

2015-12-09

Expected to finish

2018-03-26

Last updated by the study team

2019-03-27

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with Hemophilia B
• Patients with von Willebrand disease (vWD)
• Patients with other rare bleeding disorders
• Unable to comply with the study protocol

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbus, Ohio, United States
• Study site — Multiple Locations, Japan
• Study site — Multiple Locations, Spain
• Study site — Multiple Locations, United Kingdom

Full record on ClinicalTrials.gov

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