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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
November 3, 2010
November 4, 2010
November 14, 2014
October 2010
April 2012   (Final data collection date for primary outcome measure)
  • 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 ]
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 ]
  • Proportion of patients who used their entire treatment at home [ Time Frame: Month 8 ]
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
Sexes Eligible for Study: Male
2 Years and older   (Child, Adult, Senior)
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 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2014