Brief Title
Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment
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
Brief 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.
Study Type
Observational
Primary Outcome
Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).
Secondary Outcome
Clinical Outcome: Change of Hemophilia A status
Condition
Hemophilia A
Intervention
Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Study Arms / Comparison Groups
Patients with moderate to severe Hemophilia A / Cohort 1
Description: Patients aged over 16 years, with documented physician-confirmed diagnosis of moderate or severe Hemophilia A (severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity ≤1%)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
272
Start Date
December 9, 2015
Completion Date
March 26, 2018
Primary Completion Date
January 17, 2018
Eligibility 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
Gender
Male
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02396862
Organization ID
17285
Secondary IDs
KG1301
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
March 2019