Clinical Trials/NCT00104455

NCT00104455CompletedPhase 1

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

Novo Nordisk A/S1 site in 1 country64 target enrollmentStarted: June 1, 2004Last updated: January 12, 2017

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Novo Nordisk A/S
Enrollment: 64
Locations: 1
Primary Endpoint: Dose Response to Recombinant Factor VIIa

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to 60 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Dose Response to Recombinant Factor VIIa

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Novo Nordisk A/S

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (1)

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