PROPACT: Retrospective Prophylaxis Patient Case Collection
NCT ID: NCT00882778
Last Updated: 2017-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
86 participants
OBSERVATIONAL
2009-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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activated recombinant human factor VII
Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
eptacog alfa (activated)
Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors
Interventions
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eptacog alfa (activated)
Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prescribed use of activated recombinant human factor VII for any type of prophylaxis with a duration of at least 30 days
Exclusion Criteria
* One or more coagulation disorders in addition to haemophilia
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Princeton, New Jersey, United States
Novo Nordisk Investigational Site
Prov. de Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Mississauga, , Canada
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Paris La Défense Cedex, , France
Novo Nordisk Investigational Site
Mainz, , Germany
Novo Nordisk Investigational Site
Dublin, , Ireland
Novo Nordisk Investigational Site
Rome, , Italy
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Crawley, , United Kingdom
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7HAEM-3695
Identifier Type: -
Identifier Source: org_study_id
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