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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2488 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Prescription is done at the discretion of the prescribing physician as part of normal clinical routine |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with congenital haemophilia and inhibitors to Factor VIII or IX.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algiers | 16035 | Algeria | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Casablanca |
| 20000 |
| Morocco |
| Muscat | Oman |
| Riyadh | 3542 | Saudi Arabia |
| Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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