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The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SANGUINATE™ | Experimental | PEG-bHb-CO |
|
| Hydroxyurea | Active Comparator | Standard of care for Sickle Cell treatment, 15 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SANGUINATE™ | Biological | 40 mg/mL intravenous infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients. | Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenny M Galvez, MD | Hospital Pablo Tobin Uribe | Principal Investigator |
| Luis F Uribe, MD | Fundacion Reina Isabel | Principal Investigator |
| Nestor Sosa, MD | Hospital Punta Pacifica | Principal Investigator |
| Angel Hernandez, MD | Fundacion BIOS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion BIOS | Barranquilla | Colombia | ||||
| Fundacion Reina Isabel |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000633826 | PEGylated carboxyhemoglobin bovine |
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Hydroxyurea |
| Drug |
Standard of care for Sickle Cell treatment, 15 mg/kg. |
|
|
| Cali |
| Colombia |
| Hospital Pablo TobinUribe | MedellĂn | Colombia |
| PAMRI | Panama City | Panama |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |