Try our beta test site

Dose Response to Recombinant Factor VIIa When Administered for Bleed

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00104455
First received: February 28, 2005
Last updated: January 11, 2017
Last verified: January 2017
  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
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

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   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104455

Locations
United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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
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, 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

Responsible Party: 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: January 11, 2017

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

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

ClinicalTrials.gov processed this record on March 28, 2017