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14 Cards in this Set
- Front
- Back
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What was Anavip designed for (Phase 3 trial)? |
It was designed pharmacokinetiely to overcome the reccuran coagulopathic disadvantages of Crofab while retaining the safety advantages. |
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Phase 3- incidence of day 5 and day 8 coagulopathy was…? |
7.8% Anavip 29.7% Crofab That’s statically significant |
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Phase 3 safety events/AE’s…Anavip vs Crofab? |
We’re similar. Anavip had the same or slightly fewer than the Crofab treatment group. |
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Phase 3 findings? |
Anavip dosed w/o maintenance dosing is safe and more effective than Crofab in preventing late or recurrent coagulopathies. Anavip could significantly reduce late bleeding after snakebite. There’s no trade-offs in safety. Anavip prevented recurrent coagulopaties in all testing sites except 1 (San Bernardino) Southern Pacific rattlesnake |
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How many patients in Phase 3 trial? |
121 114 completed the study 18 sites Ages 2-80 |
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Phase 3 compared dosing regiments of…? |
Anavip (87) while using placebo for maintenance dosing. Crofab (46 patients) |
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What type of study was the Phase 2 study? |
Prospective, randomized, open label, multi-center study. Comparing Anavip and Crofab. Patients were between 18-70. 12 patients |
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Phase 2 study objectives? |
Was to demonstrate that Anavip has significantly longer plasma persistence than Crofab. This is associated with a slower rise in venom levels. PPP |
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Phase 2 result… |
Venom levels were clearly different. Levels in Anavip group were undetectable (100%). No recurring coagulopathy Levels in Crofab group increased. 4 of 6.
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Phase 2 adverse events? |
Similar with both groups. Majority of AE’s in both groups were assessed as mild. ItchingPuritas, nausea, chills |
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What kind of study was Phase 3? |
123 patients…. Randomized, double blinded, controlled multi center study |
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Phase 3 used Snakebite Severity Score…. What’s that? |
It’s to demonstrate all arms are balanced. It’s a validated scale to assess the severity of envenomation using 6 body catagories: local wound, pulmonary, gastro,cardiovascular,hematologic, nervous system effects. Done with physician assessment at initial patient presentation. |
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Phase 3 minimum fibrinogen result? |
The levels were greater for both Anavip groups when compared to Crofab group. Increased levels increase blood clot???? |
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Phase 3 incidence of recurring coagulopathy? |
8% Anavip group 1 29.7% Crofab (group 3) |
