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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: Completed Phase 4 study of Snake Bites, sponsored by BTG International.
NCT01864200 is a Phase 4 study of Snake Bites that has completed, run by BTG International. The registered enrollment target is 74 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patient Specific Functional Scale (PSFS) at 14 day follow-up This is a three-item instrument, administered verbally, that is used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify "up to three important activities that you are unable to do or are having difficulty with as a result of your (snakebite)." The patient then provides a rating for each item, on an 11-point o
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 |
What the finished NCT01864200 record still lists
NCT01864200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
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 lists 18 locations in 9 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01864200's enrollment target sits among peer trials
74 1027th of 2000 higher than 968 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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