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

• Status: Completed
• Trial end date: 2018-03-26
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

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