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Dose Response to Recombinant Factor VIIa When Administered for Bleed

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: February 28, 2005
Last updated: June 15, 2012
Last verified: March 2012
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
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:

Further study details as provided by Novo Nordisk A/S:

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)

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00104455

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

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S 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 A/S:
Punch Biopsy
Dose Response
Healthy People Programs

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on October 28, 2016