drugset / Trial / NCT00636116
Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.
Phase 3
Completed
121 enrolled
Instituto Bioclon S.A. de C.V.
Universidad Nacional Autonoma de Mexico · collabUniversity of Arizona · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.
Timeline
- Start
- 2008-05
- Primary completion
- 2011-11
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTIVENIN (CROTALIDAE) POLYVALENT | Protein / enzyme biologic | — | — |
| Comparator | CroFab | Protein / enzyme biologic | — | — |