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NCT00868309 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,
A Phase 2 study of Blood Coagulation Disorders and Snake Bite, sponsored by Instituto Bioclon S.A. de C.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00868309: Completed Phase 2 study of Blood Coagulation Disorders and Snake Bite, sponsored by Instituto Bioclon S.A. de C.V..
NCT00868309 is a Phase 2 study of Blood Coagulation Disorders and Snake Bite that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 12 participants, below the 261-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868309, a Phase 2 study of Blood Coagulation Disorders and Snake Bite, has completed, sponsored by Instituto Bioclon S.A. de C.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae \[pit viper\] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against CroFab (Protherics Inc., Nashville, Tennessee), the only currently approved product for treatment of Crotalinae (pit viper) envenomation in the US. The study was designed to evaluate the hypothesis that lasting correction of snakebite induced thrombocytopenia and hypofibrinogenemia are possible following correction with F(ab)2 antivenom, by analyzing in detail the relationships among platelet count, fibrinogen, venom levels, and antivenom levels in subjects presenting with thrombocytopenia following crotaline viper envenomation. In the study we expected to see a fall in platelet count following Fab treatment, commensurate with that reported in the past. We hypothesized that following F(ab)2 treatment there would be a slower drop in post-treatment platelet counts, with a relatively higher platelet count at any given point in the follow-up period. We further hypothesized that an initial rise and later fall in platelet count would correspond with rise and fall in antivenom levels, and would be mirrored by concurrent drop and rise in levels of unbound circulating venom.
Conditions Studied
Interventions
- BIOLOGICAL Anavip
- BIOLOGICAL CroFab
Study Locations (1)
Arizona
- Tucson snakebite investigational site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-01 |
| Est. Completion | 2007-02 |
| Phase | Phase 2 |
What the finished NCT00868309 record still lists
NCT00868309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 261-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Blood Coagulation Disorders appearing as the primary indexed condition, and to 2 interventions - of which Anavip is the first listed.
NCT00868309 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT00868309 about?
NCT00868309 is a clinical study titled "A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,". This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae \[pit viper\] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against CroFab (Protherics Inc., N...
What is the current status of trial NCT00868309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2005-01. Estimated completion is 2007-02.
What conditions does trial NCT00868309 study?
This clinical trial studies the following conditions: Blood Coagulation Disorders, Snake Bite.
What interventions are being tested in trial NCT00868309?
The interventions under investigation include: Anavip (BIOLOGICAL), CroFab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00868309?
This trial is sponsored by Instituto Bioclon S.A. de C.V., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00868309 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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