Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Conditions
Brief summary
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.
Interventions
DRUGactivated recombinant human factor VII
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bleeds managed at home | Month 8 |
| Number of treatments resulting in the control of bleeding episode | within 9 hours after the first injection of study product |
| Number of treatments resulting in effective pain relief | within 9 hours after the first injection of study product |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home | Month 8 |
| Proportion of patients who used their entire treatment at home | Month 8 |
Countries
Algeria, Morocco, Oman, Saudi Arabia, United Arab Emirates
Outcome results
None listed