Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation
Completed · Phase 4 · Has a placebo group
Conditions studied: Snake Bites
In brief
This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects received CroFab antivenom or placebo. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite as well as follow-up telephone assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom vs placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up. The primary efficacy endpoint of this study was achieved.
Key facts
- Study ID
- NCT01864200
- Run by
- BTG International Inc.
- People needed
- 74
- Starts
- 2013-07-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2017-11-22
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Georgia Regents University — Augusta, Georgia, United States
- University of Kansas Hospital — Kansas City, Kansas, United States
- Washington University — St Louis, Missouri, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- Vidant Medical Center — Greenville, North Carolina, United States
- Lehigh Valley Hospital Center — Allentown, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Palmetto Health Richland — Columbia, South Carolina, United States
- St Joseph Regional Health Center — Bryan, Texas, United States
- University of Texas - Southwestern — Dallas, Texas, United States
- Ben Taub General Hospital — Houston, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Scott & White Hospital — Temple, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Marshall Health — Huntington, West Virginia, United States
Full record on ClinicalTrials.gov
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