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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01561950
Other study ID # F7HAEM-1955
Secondary ID
Status Terminated
Phase Phase 1
First received March 21, 2012
Last updated November 22, 2016
Start date May 2008
Est. completion date January 2009

Study information

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

Clinical Trial Summary

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®).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
eptacog alfa (activated)
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
clopidogrel
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
placebo
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

Locations

Country Name City State
United States Novo Nordisk Investigational Site Neptune New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

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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