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Trial of NovoSeven® in Haemophilia - Joint Bleeds

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Intervention: activated recombinant human factor VII (Drug); Feiba VH (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Michael Tillinger, Study Director, Affiliation: Novo Nordisk A/S

Summary

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.

Clinical Details

Official 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®

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparison with FEIBA on review of pain, joint mobility and circumference

Secondary outcome: Safety variables

Eligibility

Minimum age: N/A. Maximum age: 20 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

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

Locations and Contacts

Novo Nordisk Clinical Trial Call Center, Little Rock, Arkansas 72202, United States

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States

Novo Nordisk Clinical Trial Call Center, Aurora, Colorado 80010, United States

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46260, United States

Novo Nordisk Clinical Trial Call Center, Iowa City, Iowa 52242, United States

Novo Nordisk Clinical Trial Call Center, New Orleans, Louisiana 70112, United States

Novo Nordisk Clinical Trial Call Center, Boston, Massachusetts 02115, United States

Novo Nordisk Clinical Trial Call Center, Detroit, Michigan 48201, United States

Novo Nordisk Clinical Trial Call Center, Minneapolis, Minnesota 55404, United States

Novo Nordisk Clinical Trial Call Center, New Brunswick, New Jersey 08903, United States

Novo Nordisk Clinical Trial Call Center, Newark, New Jersey 07112, United States

Novo Nordisk Clinical Trial Call Center, New York, New York 10029-6574, United States

Novo Nordisk Clinical Trial Call Center, Chapel Hill, North Carolina 27599-7220, United States

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45229, United States

Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19104, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19134-1095, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77030, United States

Additional Information

Clinical Trials at Novo Nordisk

Starting date: September 2001
Last updated: April 12, 2013

Page last updated: August 23, 2015

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