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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104455

Enrollment

Registered

2005-03-01

Start date

2004-06-30

Completion date

2004-11-30

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Healthy

Keywords

rFVIIa, Punch Biopsy, Dose Response, Healthy People Programs

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.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Ages Eligible for Study: 18 Years - 60 Years

Exclusion criteria

* \- -

Design outcomes

Primary

Measure	Time frame
Dose Response to Recombinant Factor VIIa	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026