Brief Title
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
Official Title
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
Brief Summary
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
Detailed Description
The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
Study Type
Observational
Primary Outcome
Total dose (IU) issued of Factor VIII during a 12 month period
Condition
Haemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1658
Start Date
March 2014
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: - Male patients with severe or moderate haemophilia A or haemophilia B. - Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study. - Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation). Exclusion Criteria: - Confirmed positive inhibitor test detected in the past 24 months.
Gender
Male
Ages
2 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stefan Lethagen, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02049099
Organization ID
Sobi.HAEM89-001
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Study Sponsor
Stefan Lethagen, MD, Study Director, Swedish Orphan Biovitrum AB (publ)
Verification Date
March 2016