Congenital Bleeding Disorder Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 2 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Algeria, Morocco, Oman, Saudi Arabia, United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of bleeds managed at home | Month 8 | No | |
| Primary | Number of treatments resulting in the control of bleeding episode | within 9 hours after the first injection of study product | No | |
| Primary | Number of treatments resulting in effective pain relief | within 9 hours after the first injection of study product | No | |
| Secondary | Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home | Month 8 | No | |
| Secondary | Proportion of patients who used their entire treatment at home | Month 8 | No |
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