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

NCT ID: NCT02049099

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1658 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

Detailed Description

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The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Conditions

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Haemophilia A Haemophilia B

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Lethagen, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum AB (publ)

Locations

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Swedish Orphan Biovitrum Investigational Site

Brussels, , Belgium

Site Status

Swedish Orphan Biovitrum Investigational Site

Montpellier, , France

Site Status

Swedish Orphan Biovitrum Investigational Site

Nantes, , France

Site Status

Swedish Orphan Biovitrum Investigational Site

Bonn, , Germany

Site Status

Swedish Orphan Biovitrum Investigational Site

Leipzig, , Germany

Site Status

Swedish Orphan Biovitrum Investigational Site

Florence, , Italy

Site Status

Swedish Orphan Biovitrum Investigational Site

Milan, , Italy

Site Status

Swedish Orphan Biovitrum Investigational Site

Vicenza, , Italy

Site Status

Swedish Orphan Biovitrum Investigational Site

Barcelona, , Spain

Site Status

Swedish Orphan Biovitrum Investigational Site

Madrid, , Spain

Site Status

Swedish Orphan Biovitrum Investigational Site

Stockholm, , Sweden

Site Status

UKHCDO

Manchester, , United Kingdom

Site Status

Countries

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Belgium France Germany Italy Spain Sweden United Kingdom

Other Identifiers

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Sobi.HAEM89-001

Identifier Type: -

Identifier Source: org_study_id

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