A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® Versus Placebo With Rescue Treatment for Copperhead Snake Envenomation (Copperhead RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by BTG International Inc.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01864200
First received: May 24, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The trial is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in regions where copperhead bites are common. 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. The subject will also be called by telephone for follow-up 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 versus placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.


Condition Intervention Phase
Agkistrodon Contortrix Envenomation
Biological: crotilidae polyvalent immune fab (ovine)
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® Versus Placebo With Rescue Treatment for Copperhead Snake Envenomation

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Patient Specific Functional Scale at Day 14 [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    compare recovery in copperhead-envenomated patients treated with CroFab® versus placebo, as measured by patient-reported outcome assessment: Patient Specific Functional Scale (PSFS) at Envenomation + Day 14 follow-up.


Estimated Enrollment: 232
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CroFab
crotilidae polyvalent immune fab (ovine) per approved labeling
Biological: crotilidae polyvalent immune fab (ovine)
crotilidae antivenom
Other Name: CroFab
Placebo Comparator: Saline placebo
Saline placebo
Biological: Placebo

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria-

  • Envenomation by a copperhead snake

    a. Snake identified by one of the following means: i.Snake or photograph of snake brought to Emergency Department ii.Patient chooses copperhead from an array of snake photographs iii.Patient envenomated in an area where only copperheads are endemic iv.Patient envenomated by a captive copperhead snake

  • Completion of informed consent and eligibility confirmation within 24 hours of envenomation
  • Envenomation on only one extremity, distal to the elbow or knee
  • Clinical evidence of mild or moderate venom effect (limb swelling and/or tenderness) is present (Venom effects need not be progressing.)
  • Patient willing and able to complete follow-up schedule of assessments
  • Patient is able to read, comprehend and sign the IRB approved consent document(s)
  • Patient is able to read and comprehend the written assessment tools (e.g., DASH, SF-36, etc.)
  • Patient is ≥14 years of age
  • Patient is sober, competent, and able to complete verbal and written informed consent

Exclusion Criteria-

  • Patient has clinical evidence of severe venom effect as defined by meeting any one of the following parameters:

    i. Swelling to an entire extremity (all major joints affected)

    1. Lower extremity: swelling crossing hip joint
    2. Upper extremity: swelling crossing shoulder joint ii. INR > 2.0 iii. Platelets <50,000 cells / µL iv. Fibrinogen <50 mg/dL

    v. Compartment syndrome vi. Systolic Blood Pressure <90 mmHg vii. More than minimal bleeding viii. Investigator's clinical discretion

  • Patient has already received antivenom for the management of the current envenomation
  • Patient is pregnant or breastfeeding
  • Patient is a prisoner
  • Patient has a distracting injury or condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of functionality status based solely on the condition of interest
  • Patient had a previous snake envenomation to any body area in the 30 days prior to screening/enrollment, regardless of whether antivenom was administered for the previous envenomation
  • Patient had an acute traumatic event, surgery, an acute medical event, or exacerbation of a pre-existing medical or surgical condition affecting the envenomated extremity within the 30 days prior to screening/enrollment
  • Patient has participated in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening that may have impact on clinical outcomes of snakebite
  • Patient has previously participated in this clinical study
  • Patient has a known history of hypersensitivity to any components of CroFab®, or to papaya or papain
  • Patient is otherwise unsuitable for inclusion in this study, based on the opinion of the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864200

Contacts
Contact: Anna Temu, BS 610-278-1660 anna.temu@btgplc.com

Locations
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Richard Schwartz, MD         
Principal Investigator: Richard Schwartz, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Steve Thornton, MD         
Principal Investigator: Steve Thornton, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63130
Contact: Michael Mullins, MD         
Principal Investigator: Michael Mullins, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Eugenia Quackenbush, MD         
Principal Investigator: Eugenia Quackenbush, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Charles Gerardo, MD         
Principal Investigator: Charles Gerardo, MD         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Eric Toschlog, MD         
Principal Investigator: Eric Toschlog, MD         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Robert Cannon, DO         
Principal Investigator: Robert Cannon, DO         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Anthony Pizon, MD         
Principal Investigator: Anthony Pizon, MD         
United States, South Carolina
MUSC Recruiting
Charleston, South Carolina, United States, 29425
Contact: Thomas Pollehn, MD         
Principal Investigator: Thomas Pollehn, MD         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: William Richardson, MD         
Principal Investigator: William Richardson, MD         
United States, Texas
St Joseph Regional Health Recruiting
Bryan, Texas, United States, 77802
Contact: Brandon Lewis, DO         
Principal Investigator: Brandon Lewis, DO         
University of Texas- Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Kapil Sharma, MD         
Principal Investigator: Kapil Sharma, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Spencer Greene, MD         
Principal Investigator: Spencer Greene, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Spencer Greene, MD         
Principal Investigator: Spencer Greene, MD         
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76502
Contact: Andrew Juergens, MD         
Principal Investigator: Andrew Juergens, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Nathan Charlton, MD         
Principal Investigator: Nathan Charlton, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Rutherfoord Rose, PharmD         
Principal Investigator: Rotherfoord Rose, PharmD         
United States, West Virginia
Marshall Health Recruiting
Huntington, West Virginia, United States, 25701
Contact: David Denning, MD         
Principal Investigator: David Denning, MD         
Sponsors and Collaborators
BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01864200     History of Changes
Other Study ID Numbers: BTG-PR005-002
Study First Received: May 24, 2013
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Poisoning
Snake Bites
Chemically-Induced Disorders
Bites and Stings
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014