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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:
ClinicalTrials.gov Identifier:
NCT00571584
First Posted: December 12, 2007
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Secondary Outcome Measures:
  • Pain assessment
  • Mobility assessment
  • Circumference of joint
  • Adverse events

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 11, 2007
First Posted: December 12, 2007
Last Update Posted: January 12, 2017
Last Verified: January 2017

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