A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

Completed

• Conditions: Haemophilia A; Haemophilia B

• Registration Number: NCT02049099
• Lead Sponsor: Swedish Orphan Biovitrum

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 Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Study Start: 2014-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1658

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total dose (IU) issued of Factor IX during a 12 month period	- 12 month to Day 0
Total dose (IU) issued of Factor VIII during a 12 month period	- 12 month to Day 0

Trial Locations

Locations (2)

Swedish Orphan Biovitrum Investigational Site; 🇸🇪 Stockholm, Sweden

UKHCDO; 🇬🇧 Manchester, United Kingdom