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NCT00636116 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.
A Phase 3 study, sponsored by Instituto Bioclon S.A. de C.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT00636116 is a Phase 3 study that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 121 participants.
The verdict
NCT00636116, a Phase 3 study, has completed, sponsored by Instituto Bioclon S.A. de C.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Crotalinae (pit viper) equine immune F(ab)2
- BIOLOGICAL Crotalidae Polyvalent Immune Fab, ovine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00636116
The ClinicalTrials.gov registry entry for NCT00636116 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Bioclon S.A. de C.V., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Crotalinae (pit viper) equine immune F(ab)2 is the first listed.
NCT00636116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00636116 about?
NCT00636116 is a clinical study titled "Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.". 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.
What is the current status of trial NCT00636116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2008-05. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00636116?
The interventions under investigation include: Crotalinae (pit viper) equine immune F(ab)2 (BIOLOGICAL), Crotalidae Polyvalent Immune Fab, ovine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00636116?
This trial is sponsored by Instituto Bioclon S.A. de C.V., which has 8 total clinical trials registered on ClinicalTrials.gov.
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