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

NCT01864200 | Completed Phase 4 Results DMC

• 1 other identifier: BTG-PR005-002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 18

Brief 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

Snake Bites

Outcome Measures

Primary Outcomes (1)

• Patient Specific Functional Scale Score

  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.

  at 14 day follow-up

Study Arms (2)

CroFab

EXPERIMENTAL

crotalidae polyvalent immune fab (ovine) per approved labeling

Biological: Crotalidae polyvalent immune fab (ovine)

Saline placebo

PLACEBO COMPARATOR

Saline placebo

Biological: Placebo

Interventions

Crotalidae polyvalent immune fab (ovine) BIOLOGICAL

crotalidae antivenom

Also known as: CroFab

CroFab

Placebo BIOLOGICAL

Saline placebo

Saline placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTG International Inc.: lead

Study Sites (18)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Lehigh Valley Hospital Center

Allentown, Pennsylvania, 18103, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29461, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

St Joseph Regional Health Center

Bryan, Texas, 77802, United States

Location

University of Texas - Southwestern

Dallas, Texas, 75235, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Scott & White Hospital

Temple, Texas, 76508, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Marshall Health

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Snake Bites

Interventions

Crotalidae Polyvalent immune Fab; Red Meat

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Shirley Steiner, Director of Clinical Operations
• Organization: BTG

shirley.steiner@btgplc.com

610 943 3631

Study Officials

• Maria Gasior, MD

  BTG International Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 22, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)