Trial of NovoSeven® in Haemophilia - Joint Bleeds

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00108797
First received: April 18, 2005
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: activated recombinant human factor VII
Drug: Feiba VH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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®

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Comparison with FEIBA on review of pain, joint mobility and circumference [ Time Frame: after 1, 3, 6, and 9 hours of treatment, respectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2001
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108797

Locations
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80010
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48201
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
New Brunswick, New Jersey, United States, 08903
Novo Nordisk Clinical Trial Call Center
Newark, New Jersey, United States, 07112
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10029-6574
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael Tillinger Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00108797     History of Changes
Other Study ID Numbers: F7HAEM-2068
Study First Received: April 18, 2005
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014