Haemophilia A Clinical Trial
Official title:
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
| Status | Completed |
| Enrollment | 1658 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 2 Years and older |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Swedish Orphan Biovitrum Investigational Site | Brussel | |
| France | Swedish Orphan Biovitrum Investigational Site | Montpellier | |
| France | Swedish Orphan Biovitrum Investigational Site | Nantes | |
| Germany | Swedish Orphan Biovitrum Investigational Site | Bonn | |
| Germany | Swedish Orphan Biovitrum Investigational Site | Leipzig | |
| Italy | Swedish Orphan Biovitrum Investigational Site | Firenze | |
| Italy | Swedish Orphan Biovitrum Investigational Site | Milano | |
| Italy | Swedish Orphan Biovitrum Investigational Site | Vicenza | |
| Spain | Swedish Orphan Biovitrum Investigational Site | Barcelona | |
| Spain | Swedish Orphan Biovitrum Investigational Site | Madrid | |
| Sweden | Swedish Orphan Biovitrum Investigational Site | Stockholm | |
| United Kingdom | UKHCDO | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Swedish Orphan Biovitrum |
Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total dose (IU) issued of Factor VIII during a 12 month period | - 12 month to Day 0 | No | |
| Primary | Total dose (IU) issued of Factor IX during a 12 month period | - 12 month to Day 0 | No |
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