drugset / Trial / NCT01826916
EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2003-11-01
- Primary completion
- 2005-12-01
- Completion
- 2006-01-01
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ecallantide | Protein / enzyme biologic | 5 mg/m2 | Intravenous |
| Subject | ecallantide | Protein / enzyme biologic | 10 mg/m2 | Intravenous |
| Subject | ecallantide | Protein / enzyme biologic | 20 mg/m2 | Intravenous |
| Subject | ecallantide | Protein / enzyme biologic | 30 mg | Intravenous |