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Dose Response to Recombinant Factor VIIa When Administered for Bleed

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00104455
First received: February 28, 2005
Last updated: June 15, 2012
Last verified: March 2012
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The purpose of this trial is to investigate the dose response to recombinant factor VIIa in healthy volunteers when administered for bleed.


Condition Intervention Phase
Congenital Bleeding Disorder
Healthy
 Drug: activated recombinant human factor VII
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Recombinant Activated Factor VII (rFVIIa/NovoSeven) Dose Response Trial in Healthy Volunteers: A Double-Blind, Placebo-Controlled, Cross-over, Dose-Escalation Trial to Investigate the Dose Response to REcombinant Factor VIIa When Administered for Bleeding Following Punch Biopsies in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Dose Response to Recombinant Factor VIIa [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: June 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

  • - -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104455

Locations
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Brett Skolnick, PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00104455     History of Changes
Other Study ID Numbers: F7DRC-2157
Study First Received: February 28, 2005
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk:
rFVIIa
Punch Biopsy
Dose Response
Healthy People Programs

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
 Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013