NCT00104455

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

February 28, 2005

Last Update Submit

January 11, 2017

Conditions

Congenital Bleeding DisorderHealthy

Keywords

rFVIIaPunch BiopsyDose ResponseHealthy People Programs

Outcome Measures

Primary Outcomes (1)

  • Dose Response to Recombinant Factor VIIa

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages Eligible for Study: 18 Years - 60 Years

You may not qualify if:

  • \- -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66211, United States

Location

Related Publications (3)

  • 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

    RESULT

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

    RESULT

  • 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

    RESULT

Related Links

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2005

First Posted

March 1, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

US(1)