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| Name | Class |
|---|---|
| Atlantic Research Group | OTHER |
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This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylaxis safety and efficacy substudy | Experimental | Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 additional exposure days. |
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| On-demand safety and efficacy substudy | Experimental | Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during additional 50 exposure days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GreenGene™ F | Biological | Prophylaxis safety and efficacy substudy: intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with development of inhibitors | Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months. | every 3 months, up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Hee Lee, M.D. | Contact | +82 31 260 9729 | chleedr@greencross.com | |
| Kevin Wait | Contact | +1 540 649 5490 | kwait@atlanticresearchgroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
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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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| GreenGene™ F | Biological | On-demand safety and efficacy substudy: minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg |
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| Long Island Jewish Medical Center - Hemophilia Treatment Center | Recruiting | New Hyde Park | New York | 11040 | United States |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |