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Clinical Trials/NCT02049099
NCT02049099
Completed
Not Applicable

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

Swedish Orphan Biovitrum2 sites in 2 countries1,658 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Haemophilia A
Sponsor
Swedish Orphan Biovitrum
Enrollment
1658
Locations
2
Primary Endpoint
Total dose (IU) issued of Factor IX during a 12 month period
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Total dose (IU) issued of Factor IX during a 12 month period

Time Frame: - 12 month to Day 0

Total dose (IU) issued of Factor VIII during a 12 month period

Time Frame: - 12 month to Day 0

Study Sites (2)

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