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High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00571584
First received: December 11, 2007
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Global treatment response of the patient by an algorithm based pain and joint mobility assessments [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain assessment [ Designated as safety issue: No ]
  • Mobility assessment [ Designated as safety issue: No ]
  • Circumference of joint [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
  • A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria:

  • Joint bleeding within 7 days prior to trial start
  • Treatment for bleeds within the last 5 days prior to trial start
  • Clinically relevant coagulation disorders other than congenital haemophilia A or B
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571584

Locations
France
Paris, France, 75015
Hungary
Budapest, Hungary, 1135
Israel
Tel-Hashomer, Israel, 52621
Spain
Madrid, Spain, 28046
Turkey
Capa-ISTANBUL, Turkey, 35100
United Kingdom
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Peter Schelde, MSc Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00571584     History of Changes
Other Study ID Numbers: F7HEAM-1510
Study First Received: December 11, 2007
Last Updated: May 21, 2012
Health Authority: Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Turkey: Ministry of Health Drug and Pharmaceutical Department

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

ClinicalTrials.gov processed this record on May 23, 2013