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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 A/S
ClinicalTrials.gov Identifier:
NCT00104455
First received: February 28, 2005
Last updated: June 15, 2012
Last verified: March 2012

February 28, 2005
June 15, 2012
June 2004
November 2004   (final data collection date for primary outcome measure)
Dose Response to Recombinant Factor VIIa [ Designated as safety issue: No ]
Dose Response to Recombinant Factor VIIa
Complete list of historical versions of study NCT00104455 on ClinicalTrials.gov Archive Site
Not Provided
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Dose Response to Recombinant Factor VIIa When Administered for Bleed
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Healthy
Drug: activated recombinant human factor VII
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
November 2004
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

  • - -
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00104455
F7DRC-2157
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Brett Skolnick, PhD Novo Nordisk A/S
Novo Nordisk A/S
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP