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Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234545
First Posted: November 4, 2010
Last Update Posted: November 14, 2014
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 Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Condition Intervention
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of bleeds managed at home [ Time Frame: Month 8 ]
  • Number of treatments resulting in the control of bleeding episode [ Time Frame: within 9 hours after the first injection of study product ]
  • Number of treatments resulting in effective pain relief [ Time Frame: within 9 hours after the first injection of study product ]

Secondary Outcome Measures:
  • Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home [ Time Frame: Month 8 ]
  • Proportion of patients who used their entire treatment at home [ Time Frame: Month 8 ]

Enrollment: 35
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: activated recombinant human factor VII
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with congenital haemophilia and inhibitors to Factor VIII or IX.
Criteria

Inclusion Criteria:

  • Patients with congenital haemophilia and inhibitors to factor VIII or IX
  • Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • 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): NCT01234545


Locations
Algeria
Algiers, Algeria, 16035
Morocco
Casablanca, Morocco, 20000
Oman
Muscat, Oman
Saudi Arabia
Riyadh, Saudi Arabia, 3542
United Arab Emirates
Dubai, United Arab Emirates
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01234545     History of Changes
Other Study ID Numbers: F7HAEM-3850
U1111-1116-2488 ( Other Identifier: WHO )
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: November 14, 2014
Last Verified: November 2014

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
Factor VIII
Coagulants