Dose Response to Recombinant Factor VIIa When Administered for Bleed

This study has been completed.

First Received: February 28, 2005 Last Updated: November 10, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00104455

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
Healthy	Drug: activated recombinant human factor VII	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Dose Response to Recombinant Factor VIIa

Estimated Enrollment:	48
Study Start Date:	June 2004

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:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7DRC-2157
Study First Received:	February 28, 2005
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00104455 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

rFVIIa
Punch Biopsy
Dose Response
Healthy People Programs

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009