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

November 3, 2010
April 8, 2013
October 2010
April 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01234545 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with congenital haemophilia and inhibitors to Factor VIII or IX.

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
Drug: activated recombinant human factor VII
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine
A
Intervention: Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Morocco,   Oman,   Saudi Arabia,   United Arab Emirates
 
NCT01234545
F7HAEM-3850, U1111-1116-2488
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Hossam Ali Novo Nordisk Pharma Gulf
Novo Nordisk A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP