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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: Completed Phase 3 study, sponsored by Instituto Bioclon S.A. de C.V..
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00636116 record still lists
NCT00636116 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00636116's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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