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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01234545
First received: November 3, 2010
Last updated: April 8, 2013
Last verified: April 2013
  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 ] [ Designated as safety issue: No ]
  • Number of treatments resulting in the control of bleeding episode [ Time Frame: within 9 hours after the first injection of study product ] [ Designated as safety issue: No ]
  • Number of treatments resulting in effective pain relief [ Time Frame: within 9 hours after the first injection of study product ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Proportion of patients who used their entire treatment at home [ Time Frame: Month 8 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years and older
Genders 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
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: 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: Hossam Ali Novo Nordisk Pharma Gulf
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01234545     History of Changes
Other Study ID Numbers: F7HAEM-3850, U1111-1116-2488
Study First Received: November 3, 2010
Last Updated: April 8, 2013
Health Authority: Algeria: Ministry of Health
Morocco: Ministry of Health
Saudi Arabia: Ministry of Health
Oman: Ministry of Health
United Arab Emirates: Ministry of Health

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
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014