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Completed Phase 4 Interventional Results available

Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation

ClinicalTrials.gov ID: NCT01864200

Public ClinicalTrials.gov record NCT01864200. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 8:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® vs Placebo With Rescue Treatment for Copperhead Snake Envenomation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01864200
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
BTG International Inc.
Other
Enrollment
74 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2013 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Nov 22, 2017

2013 – 2015

United States locations

U.S. sites
18
U.S. states
9
U.S. cities
17
Facility City State ZIP Site status
Georgia Regents University Augusta Georgia 30912 —
University of Kansas Hospital Kansas City Kansas 66160 —
Washington University St Louis Missouri 63110 —
University of North Carolina Chapel Hill North Carolina 27599 —
Duke University Durham North Carolina 27710 —
Vidant Medical Center Greenville North Carolina 27834 —
Lehigh Valley Hospital Center Allentown Pennsylvania 18103 —
University of Pittsburgh Pittsburgh Pennsylvania 15261 —
Medical University of South Carolina Charleston South Carolina 29461 —
Palmetto Health Richland Columbia South Carolina 29203 —
St Joseph Regional Health Center Bryan Texas 77802 —
University of Texas - Southwestern Dallas Texas 75235 —
Ben Taub General Hospital Houston Texas 77030 —
Texas Children's Hospital Houston Texas 77030 —
Scott & White Hospital Temple Texas 76508 —
University of Virginia Charlottesville Virginia 22908 —
Virginia Commonwealth University Richmond Virginia 23219 —
Marshall Health Huntington West Virginia 25701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01864200, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 22, 2017 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01864200 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →