A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
1 other identifier
observational
1,658
7 countries
12
Brief Summary
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 14, 2016
March 1, 2016
1.5 years
January 28, 2014
March 11, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Total dose (IU) issued of Factor VIII during a 12 month period
- 12 month to Day 0
Total dose (IU) issued of Factor IX during a 12 month period
- 12 month to Day 0
Eligibility Criteria
The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.
You may qualify if:
- Male patients with severe or moderate haemophilia A or haemophilia B.
- Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).
You may not qualify if:
- Confirmed positive inhibitor test detected in the past 24 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Swedish Orphan Biovitrum Investigational Site
Brussels, Belgium
Swedish Orphan Biovitrum Investigational Site
Montpellier, France
Swedish Orphan Biovitrum Investigational Site
Nantes, France
Swedish Orphan Biovitrum Investigational Site
Bonn, Germany
Swedish Orphan Biovitrum Investigational Site
Leipzig, Germany
Swedish Orphan Biovitrum Investigational Site
Florence, Italy
Swedish Orphan Biovitrum Investigational Site
Milan, Italy
Swedish Orphan Biovitrum Investigational Site
Vicenza, Italy
Swedish Orphan Biovitrum Investigational Site
Barcelona, Spain
Swedish Orphan Biovitrum Investigational Site
Madrid, Spain
Swedish Orphan Biovitrum Investigational Site
Stockholm, Sweden
UKHCDO
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stefan Lethagen, MD
Swedish Orphan Biovitrum AB (publ)
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 29, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 14, 2016
Record last verified: 2016-03