- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864200
Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation (Copperhead)
A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® vs Placebo With Rescue Treatment for Copperhead Snake Envenomation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Regents University
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Hospital
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Greenville, North Carolina, United States, 27834
- Vidant Medical Center
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital Center
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
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South Carolina
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Charleston, South Carolina, United States, 29461
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health Richland
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Texas
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Bryan, Texas, United States, 77802
- St Joseph Regional Health Center
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Dallas, Texas, United States, 75235
- University of Texas - Southwestern
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Houston, Texas, United States, 77030
- Ben Taub General Hospital
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Temple, Texas, United States, 76508
- Scott & White Hospital
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Richmond, Virginia, United States, 23219
- Virginia Commonwealth University
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West Virginia
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Huntington, West Virginia, United States, 25701
- Marshall Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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, LEFS, PROMIS Physical Function Short Form 10a (PROMIS PF-10), PGIC, etc.)
- Patient is ≥12 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)
- Lower extremity: swelling crossing hip joint
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CroFab
crotalidae polyvalent immune fab (ovine) per approved labeling
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crotalidae antivenom
Other Names:
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Placebo Comparator: Saline placebo
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Saline placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Specific Functional Scale Score
Time Frame: at 14 day follow-up
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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 ordinal scale ranging from 0 ("unable to perform activity") to 10 ("able to perform activity at the same level as before the injury or problem").
During reassessments, the subject is prompted to re-rate the same three activities.
The average of up to 3 specific activity scores was recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment.
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at 14 day follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Gasior, MD, BTG International Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTG-PR005-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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