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Completed

NCT Number: NCT00108797

Trial of NovoSeven® in Haemophilia - Joint Bleeds

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Age range

Up to 20 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively

Treatment and study plan

eptacog alfa (activated)

Drug

Other names: activated recombinant human factor VII

Feiba VH

Drug

Primary outcomes

  1. Comparison with FEIBA on review of pain, joint mobility and circumference

    Time frame: after 1, 3, 6, and 9 hours of treatment, respectively

Secondary outcomes

  1. Safety variables

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Apr 19, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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