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NCT00104455 Clinical Trial

Dose Response to Recombinant Factor VIIa When Administered for Bleed

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00104455
Other study ID # F7DRC-2157
Secondary ID
Status Completed
Phase Phase 1
First received February 28, 2005
Last updated January 11, 2017
Start date June 2004
Est. completion date November 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date November 2004
Est. primary completion date November 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII

Locations
Country Name City State
United States Novo Nordisk Investigational Site Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gabriel DA, Skolnick BE, Leese P, Mathews D. Ex-vivo Assessments in the Evaluation of Dose Response to Recombinant Factor VIIa when Administered for Bleeding Following Punch Biopsies in Healthy Volunteers. Blood 2005; 106 (11): Abstract No. 4055

Gabriel DA, Skolnick BE, Rojkjaer LP, Seremetis SV. Variations in Ex-Vivo Assessments of Hemostasis. Blood 2005; 106 (11): Abstract No. 4052

Gabriel DA, SKolnick BE, S Seremitis, Leese P, Mathews D. Effect of Recombinant Activated Factor VII (rFVIIa) on Platelet and Clotting Systems in Healthy Volunteers. Blood 2005; 106 (11): Abstract No. 4053

Outcome
Type Measure Description Time frame Safety issue
Primary Dose Response to Recombinant Factor VIIa No
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