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

March 11, 2016 updated by: Swedish Orphan Biovitrum
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • Swedish Orphan Biovitrum Investigational Site
  • France
      • Montpellier, France
        • Swedish Orphan Biovitrum Investigational Site
      • Nantes, France
        • Swedish Orphan Biovitrum Investigational Site
  • Germany
      • Bonn, Germany
        • Swedish Orphan Biovitrum Investigational Site
      • Leipzig, Germany
        • Swedish Orphan Biovitrum Investigational Site
  • Italy
      • Firenze, Italy
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Italy
        • Swedish Orphan Biovitrum Investigational Site
      • Vicenza, Italy
        • Swedish Orphan Biovitrum Investigational Site
  • Spain
      • Barcelona, Spain
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Spain
        • Swedish Orphan Biovitrum Investigational Site
  • Sweden
      • Stockholm, Sweden
        • Swedish Orphan Biovitrum Investigational Site
  • United Kingdom
      • Manchester, United Kingdom
        • UKHCDO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Investigators

  • Study Director: Stefan Lethagen, MD, Swedish Orphan Biovitrum AB (publ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.HAEM89-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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