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Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

NCT ID: NCT00375323

Last Updated: 2007-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Interventions

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NovoSeven

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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 NovoSevenīƒ’ or any of its components
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Sabine Eichinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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NovoSeven 1

Identifier Type: -

Identifier Source: org_study_id