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NCT01864200 · ClinicalTrials.gov registry record · Phase 4
Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation
A Phase 4 study of Snake Bites, sponsored by BTG International.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
- 18
- Study locations
NCT01864200 is a Phase 4 study of Snake Bites that has completed, run by BTG International. The registered enrollment target is 74 participants. The trial reports 18 study locations across 9 states.
The verdict
NCT01864200, a Phase 4 study of Snake Bites, has completed, sponsored by BTG International.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Crotalidae polyvalent immune fab (ovine)
Study Locations (18)
Texas
- St Joseph Regional Health Center - Bryan
- University of Texas - Southwestern - Dallas
- Ben Taub General Hospital - Houston
- Texas Children's Hospital - Houston
- Scott & White Hospital - Temple
North Carolina
- University of North Carolina - Chapel Hill
- Duke University - Durham
- Vidant Medical Center - Greenville
Pennsylvania
- Lehigh Valley Hospital Center - Allentown
- University of Pittsburgh - Pittsburgh
South Carolina
- Medical University of South Carolina - Charleston
- Palmetto Health Richland - Columbia
Virginia
- University of Virginia - Charlottesville
- Virginia Commonwealth University - Richmond
Georgia
- Georgia Regents University - Augusta
Kansas
- University of Kansas Hospital - Kansas City
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01864200
The ClinicalTrials.gov registry entry for NCT01864200 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BTG International, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Snake Bites appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01864200 reports 18 study locations spanning 9 distinct geographic areas - top geographies include Texas, North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01864200 about?
NCT01864200 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation". 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 s...
What is the current status of trial NCT01864200?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2013-07. Estimated completion is 2015-12.
What conditions does trial NCT01864200 study?
This clinical trial studies the following conditions: Snake Bites.
What interventions are being tested in trial NCT01864200?
The interventions under investigation include: Placebo (BIOLOGICAL), Crotalidae polyvalent immune fab (ovine) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01864200?
This trial is sponsored by BTG International, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01864200 being conducted?
This trial has 18 study locations across Georgia, Kansas, Missouri, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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