Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
NCT ID: NCT01561391
Last Updated: 2023-12-29
Study Results
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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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
1998-04-30
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous infusion
activated recombinant human factor VII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
Bolus injection
activated recombinant human factor VII
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
Control
factor IX
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
factor VIII
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Interventions
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activated recombinant human factor VII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
activated recombinant human factor VII
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
factor IX
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
factor VIII
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Eligibility Criteria
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Inclusion Criteria
* Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
* Require pre-planned major surgery in hospital
Exclusion Criteria
* Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
* Have any haemostatic disorder other than haemophilia
5 Years
ALL
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
Los Angeles, California, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Rochester, Minnesota, United States
Novo Nordisk Investigational Site
New Brunswick, New Jersey, United States
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Countries
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References
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Pruthi RK, Mathew P, Valentino LA, Sumner MJ, Seremetis S, Hoots WK; NovoSeven in Surgery Study Investigators. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial. Thromb Haemost. 2007 Oct;98(4):726-32.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7HAEM/USA/4/USA
Identifier Type: -
Identifier Source: org_study_id