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Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast
Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast.
Duration of the study: 1 year after initiation of prophylaxis with Emicizumab
Inclusion criteria: boys aged > 2 years, affected with severe hemophilia A with or without inhibitors
Evaluated outcomes: annual bleeding rate, days of absence from school, the need for additional facteur VIII consumption, satisfaction about the treatment and quality of life.
Tools used to assess quality of life are the Ivoirian version of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version 2 (CHO-KLAT) and EQ-5D
The satisfaction of the parents will be assessed using the patients' global impression of change scale (PGIC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivoirian Boys with severe Hemophilia A treated with Emicizumab | Experimental | All Ivoirian boys with severe Hemophilia A (with and without inhibitors) on prophylaxis with Emicizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylaxis with Emicizumab | Drug | Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in annual bleeding rate | Using the patients' logbook | change in annual bleeding rate from baseline at 6 months and 12 months |
| Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D in children treated with Emicizumab | Using the CHO-KLAT and EQ-5D. The scales range from 0 to 100 with 0 representing the worst quality of life and 100 the best quality of life score | Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D at 6 months. |
| Satisfaction of the parents about the treatment with Emicizumab after 6 month | Usign the PGIC (scale ranging from extremely satisfied to extremely unsatisfied) | Assessment at 6 months after initiation of Emicizumab |
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Inclusion Criteria: severe hemophilia A with or without inhibitors -
Exclusion Criteria: parents refusal
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| Name | Affiliation | Role |
|---|---|---|
| N'Dogomo Meité, MD | CHU de Cocody | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Yopougon | Abidjan | Côte d’Ivoire |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000608208 | emicizumab |
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outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |