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


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Trial ID: NCT02396862


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.

Official Title

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

Stanford Investigator(s)


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

   - 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


drug: Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305