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.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: November 3, 2010
Last updated: April 8, 2013
Last verified: April 2013

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


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.


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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234545

Algiers, Algeria, 16035
Casablanca, Morocco, 20000
Muscat, Oman
Saudi Arabia
Riyadh, Saudi Arabia, 3542
United Arab Emirates
Dubai, United Arab Emirates
Sponsors and Collaborators
Novo Nordisk A/S
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
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014