Drugs / CroFab
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT00868309 Comparator | Jan 2005 → Aug 2006 | blood coagulation disease, snakebite envenomation | Instituto Bioclon S.A. de C.V. | Completed | No outcome recorded |
| Phase 3 | NCT00636116 Comparator | May 2008 → Nov 2011 | snakebite envenomation | Instituto Bioclon S.A. de C.V. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-05-02 | Orphan Australia | Results New Publication Compares Total Vials of CroFab® and Anavip® Administered to Treat US Rattlesnake Envenomation serb.com ↗
The total number of vials of CroFab® was significantly less than the number of vials of Anavip® required for the treatment of rattlesnake envenomations, at a ratio of 1.8 vials of Anavip to 1 vial of CroFab® (P<0.0001). |
| 2019-04-29 | Orphan Australia | Results Trial finds patients receiving CroFab® antivenom less likely to use opioids for pain control serb.com ↗ |
| 2019-03-05 | Orphan Australia | Results New research validates clinical value of treating Copperhead envenomation with CroFab® serb.com ↗
Today’s paper shows that not only was there a statistically significant difference between patients treated with CroFab® and the placebo group in the Copperhead trial, but that the difference is also clinically meaningful. |
| 2018-09-13 | Orphan Australia | Regulatory FDA Approves CroFab® Product Improvements serb.com ↗
BTG plc (LSE: BTG) announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab® Crotalidae Polyvalent Immune Fab (Ovine) to 60 months and the removal of mercury from the product’s manufacturing process. |
| 2017-06-13 | Orphan Australia | Results New Study Shows Patients Treated With CroFab® Have Improved Recovery From Copperhead Envenomation serb.com ↗
For the first time, this data demonstrates that CroFab® improves recovery of limb function from Copperhead envenomation. |
| 2016-03-09 | Orphan Australia | Results New Data from Largest Prospective Study on CroFab® for Treatment of Copperhead Snake Envenomation serb.com ↗
Patients treated early with CroFab® were more fully recovered (day 14 least squares mean PSFS score difference +1.176, p=0.036). |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-05-02 | Orphan Australia | New Publication Compares Total Vials of CroFab® and Anavip® Administered to Treat US Rattlesnake Envenomation serb.com ↗ |
| 2019-04-29 | Orphan Australia | Trial finds patients receiving CroFab® antivenom less likely to use opioids for pain control serb.com ↗ |
| 2019-03-05 | Orphan Australia | New research validates clinical value of treating Copperhead envenomation with CroFab® serb.com ↗ |
| 2018-09-13 | Orphan Australia | FDA Approves CroFab® Product Improvements serb.com ↗ |
| 2017-06-13 | Orphan Australia | New Study Shows Patients Treated With CroFab® Have Improved Recovery From Copperhead Envenomation serb.com ↗ |
| 2016-03-09 | Orphan Australia | New Data from Largest Prospective Study on CroFab® for Treatment of Copperhead Snake Envenomation serb.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CroFab | “Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae...” NCT00636116 ↗ |
| Modality | Protein / enzyme biologic | “Fab antivenom” NCT00636116 ↗ |
| Route | Intravenous | “Intravenous (IV)” NCT00868309 ↗ |