NCT02049099

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

January 28, 2014

Last Update Submit

March 11, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

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

    - 12 month to Day 0

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

    - 12 month to Day 0

Eligibility Criteria

Age2 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Male patients with severe or moderate haemophilia A or haemophilia B.
  • Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).

You may not qualify if:

  • Confirmed positive inhibitor test detected in the past 24 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Swedish Orphan Biovitrum Investigational Site

Brussels, Belgium

Location

Swedish Orphan Biovitrum Investigational Site

Montpellier, France

Location

Swedish Orphan Biovitrum Investigational Site

Nantes, France

Location

Swedish Orphan Biovitrum Investigational Site

Bonn, Germany

Location

Swedish Orphan Biovitrum Investigational Site

Leipzig, Germany

Location

Swedish Orphan Biovitrum Investigational Site

Florence, Italy

Location

Swedish Orphan Biovitrum Investigational Site

Milan, Italy

Location

Swedish Orphan Biovitrum Investigational Site

Vicenza, Italy

Location

Swedish Orphan Biovitrum Investigational Site

Barcelona, Spain

Location

Swedish Orphan Biovitrum Investigational Site

Madrid, Spain

Location

Swedish Orphan Biovitrum Investigational Site

Stockholm, Sweden

Location

UKHCDO

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Stefan Lethagen, MD

    Swedish Orphan Biovitrum AB (publ)

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 29, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations