Dose Response to Recombinant Factor VIIa When Administered for Bleed

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00104455
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder; Healthy	Drug: activated recombinant human factor VII	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Nov 1, 2004
• Actual Study Completion Date: Nov 1, 2004

Outcome Measures

Primary Outcome Measures

1. Dose Response to Recombinant Factor VIIa []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00104455
• Other Study ID Numbers: F7DRC-2157
• First Posted: Mar 1, 2005
• Last Update Posted: Jan 12, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Novo Nordisk A/S: rFVIIa; Punch Biopsy; Dose Response; Healthy People Programs
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage

Study Results

No Results Posted as of Jan 12, 2017