Healthy Clinical Trial
Official title:
Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
Verified date | November 2016 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
Status | Terminated |
Enrollment | 91 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0) - Platelet count within normal laboratory range Exclusion Criteria: - The receipt of any investigational drug within 1 month prior to this trial - Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin - (or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial - African-American race - Weight above or equal to 160 kg |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Novo Nordisk Investigational Site | Neptune | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding duration measured in minutes | From onset of bleeding till the end of the bleeding | No | |
Secondary | Blood volume reported in millilitres | From onset of bleeding till the end of the bleeding | No | |
Secondary | Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes | Time to onset of clot formation | No | |
Secondary | Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes | Time to achieve 20 mm clot strength | No | |
Secondary | Adverse events, including thrombotic events | From screening to day 11-18 | No | |
Secondary | Change in coagulation-related parameters after pre-biopsy | From baseline to 15 minutes after pre-biopsy | No | |
Secondary | Change in coagulation-related parameters after biopsy B2 | From baseline to 3 hours after B2 | No | |
Secondary | Change in coagulation-related parameters after biopsy B3 | From baseline to 1 hour after B3 | No |
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