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| ID | Type | Description | Link |
|---|---|---|---|
| EDEMA2 | Other Identifier | Dyax |
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EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5mg/m2 DX-88 IV | Experimental | 5mg/m2 DX-88 (ecallantide)administered intravenously |
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| 10mg/m2 DX-88 IV | Experimental | 10mg/m2 DX-88(ecallantide)administered intravenously |
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| 20mg/m2 DX-88 IV | Experimental | 20mg/m2 DX-88 (ecallantide) administered intravenously |
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| 30 mg DX-88 SC | Experimental | 30mg DX-88(ecallantide)administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DX-88 (ecallantide) | Drug | solution for injection 10 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of attacks treated with successful outcome | successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours | 24 hours |
| Proportion of attacks with a partial response | partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response | 24 hours | |
| Time to resolution onset of each acute attack, as determined by patient report | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24712435 | Derived | Rubinstein E, Stolz LE, Sheffer AL, Stevens C, Bousvaros A. Abdominal attacks and treatment in hereditary angioedema with C1-inhibitor deficiency. BMC Gastroenterol. 2014 Apr 9;14:71. doi: 10.1186/1471-230X-14-71. | |
| 23878046 | Derived | MacGinnitie AJ, Davis-Lorton M, Stolz LE, Tachdjian R. Use of ecallantide in pediatric hereditary angioedema. Pediatrics. 2013 Aug;132(2):e490-7. doi: 10.1542/peds.2013-0646. Epub 2013 Jul 22. |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C511194 | ecallantide |
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| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |