Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy
NCT ID: NCT01562821
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
235 participants
INTERVENTIONAL
2001-07-31
2002-12-31
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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Low dose
activated recombinant human factor VII
An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery
High dose
activated recombinant human factor VII
An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery
Placebo
placebo
An initial placebo bolus dose followed by placebo every second hour until completion of surgery
Interventions
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activated recombinant human factor VII
An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery
activated recombinant human factor VII
An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery
placebo
An initial placebo bolus dose followed by placebo every second hour until completion of surgery
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
Exclusion Criteria
* Clinically documented DVT (deep venous thrombosis)
* Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
* Present renal insufficiency requiring dialysis
21 Years
70 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
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China
Novo Nordisk Investigational Site
Beijing, , China
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Countries
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References
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Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, Nivatvongs S, Lee PH. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006 Feb;191(2):245-9. doi: 10.1016/j.amjsurg.2005.10.019.
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-1313
Identifier Type: -
Identifier Source: org_study_id
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