Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
NCT ID: NCT01563458
Last Updated: 2017-01-13
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
PHASE2
208 participants
INTERVENTIONAL
2001-08-31
2003-08-31
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
DOUBLE
Study Groups
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High dose
activated recombinant human factor VII
120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
Low dose
activated recombinant human factor VII
60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
Placebo
placebo
Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
Interventions
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activated recombinant human factor VII
120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
activated recombinant human factor VII
60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
placebo
Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
Eligibility Criteria
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Inclusion Criteria
* Liver disease classified as Child-Turcotte (Pughs modification) score B or C
Exclusion Criteria
* Scheduled multi-organ transplantation
* Scheduled for living related donor transplantation
* Present renal insufficiency requiring dialysis
* Pregnancy
18 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
Camperdown, , Australia
Novo Nordisk Investigational Site
Heidelberg, , Australia
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada
Novo Nordisk Investigational Site
London, , Canada
Novo Nordisk Investigational Site
Québec, , Canada
Novo Nordisk Investigational Site
Toronto, , Canada
Novo Nordisk Investigational Site
Clichy, , France
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Essen, , Germany
Novo Nordisk Investigational Site
Barakaldo, , Spain
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Edinburgh, , United Kingdom
Novo Nordisk Investigational Site
Leeds, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Countries
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References
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Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl. 2005 Aug;11(8):973-9. doi: 10.1002/lt.20470.
Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7LIVER-1256
Identifier Type: -
Identifier Source: org_study_id
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