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.

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Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

2 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Swedish Orphan Biovitrum Investigational Site, Brussels, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: - 12 month to Day 0
Total dose (IU) issued of Factor IX during a 12 month period

Time frame: - 12 month to Day 0

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 29, 2014
Registry last updated: Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed