NCT00375323

Brief Summary

The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on restoring coagulation activation between patients with hemophilia A and antibodies to factor VIII and normal subjects (controls) by use of an in vivo method.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 11, 2006

Last Update Submit

April 19, 2007

Conditions

Hemophilia A

Keywords

factor VIII inhibitor

Interventions

NovoSevenDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with hemophilia A and current antibodies to factor VIII -

You may not qualify if:

  • Life-threatening hemorrhage
  • Severe liver failure
  • Any other severe co-morbidity (including diabetes mellitus, renal failure, cancer, septicemia, disseminated intravascular coagulation, crush injury)
  • Exposure to other haemostatic drugs during the previous 7 days
  • Hypersensitivity to hamster, mouse or bovine proteins
  • Known or suspected allergy to NovoSeven or any of its components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sabine Eichinger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

AU(1)