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Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

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ClinicalTrials.gov Identifier: NCT01561950
Recruitment Status : Terminated
First Posted : March 23, 2012
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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®).

Condition or disease Intervention/treatment Phase
Haemostasis Healthy Drug: eptacog alfa (activated) Drug: clopidogrel Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Factor VII 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
Other Name: activated recombinant human factor VII
Drug: 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 Comparator: Placebo Drug: 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).
Drug: 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


Outcome Measures

Primary Outcome Measures :
  1. Bleeding duration measured in minutes [ Time Frame: From onset of bleeding till the end of the bleeding ]

Secondary Outcome Measures :
  1. Blood volume reported in millilitres [ Time Frame: From onset of bleeding till the end of the bleeding ]
  2. Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes [ Time Frame: Time to onset of clot formation ]
  3. Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes [ Time Frame: Time to achieve 20 mm clot strength ]
  4. Adverse events, including thrombotic events [ Time Frame: From screening to day 11-18 ]
  5. Change in coagulation-related parameters after pre-biopsy [ Time Frame: From baseline to 15 minutes after pre-biopsy ]
  6. Change in coagulation-related parameters after biopsy B2 [ Time Frame: From baseline to 3 hours after B2 ]
  7. Change in coagulation-related parameters after biopsy B3 [ Time Frame: From baseline to 1 hour after B3 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561950


Locations
United States, New Jersey
Novo Nordisk Investigational Site
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561950     History of Changes
Other Study ID Numbers: F7HAEM-1955
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors