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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00571584
First received: December 11, 2007
Last updated: January 11, 2017
Last verified: January 2017
  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:


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

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

Ages Eligible for Study:   Child, Adult, Senior
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
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: NCT00571584

Locations
France
Novo Nordisk Investigational Site
Kremlin-Bicêtre, France, 94270
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
Lyon, France, 69003
Novo Nordisk Investigational Site
Paris, France, 75014
Novo Nordisk Investigational Site
Paris, France, 75015
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1135
Israel
Novo Nordisk Investigational Site
Tel-Hashomer, Israel, 52621
Poland
Novo Nordisk Investigational Site
Poznan, Poland, 61-833
Novo Nordisk Investigational Site
Warszawa, Poland, 00-576
Novo Nordisk Investigational Site
Warszawa, Poland, 00-791
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-345
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Turkey
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Capa-ISTANBUL, Turkey, 35100
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B15 2TH
Novo Nordisk Investigational Site
Canterbury, United Kingdom
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: January 11, 2017
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:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 17, 2017