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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01562821 |
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Date of registration:
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22/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy
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Scientific title:
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A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours |
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Date of first enrolment:
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July 2001 |
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Target sample size:
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235 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01562821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Taiwan
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Thailand
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cirrhosis (Child-Turcotte Score A, B, or C)
- Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
Exclusion Criteria:
- Portal vein thrombosis
- 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
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acquired Bleeding Disorder
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Cirrhosis
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Intervention(s)
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Drug: placebo
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Drug: activated recombinant human factor VII
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Primary Outcome(s)
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The RBC transfusion requirements
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Secondary Outcome(s)
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Change in coagulation-related parameters
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Adverse events
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Number of transfusion product units
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Secondary ID(s)
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F7LIVER-1313
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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