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

NCT ID: NCT01864200

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

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 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. Treatment with CroFab® demonstrated measurable and significant improvement (less disability) over placebo: in the mITT population, the LS mean total score on the PSFS at Day 14 follow-up and treatment showed less disability in patients randomized to receive CroFab® than those receiving placebo.

Conditions

Snake Bites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CroFab

crotalidae polyvalent immune fab (ovine) per approved labeling

Group Type: EXPERIMENTAL

Crotalidae polyvalent immune fab (ovine)

Intervention Type: BIOLOGICAL

crotalidae antivenom

Saline placebo

Saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Saline placebo

Interventions

Crotalidae polyvalent immune fab (ovine)

crotalidae antivenom

Intervention Type: BIOLOGICAL

Placebo

Saline placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

CroFab

Eligibility 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, 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)

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Gasior, MD

Role: PRINCIPAL_INVESTIGATOR

BTG International Inc.

Locations

Georgia Regents University

Augusta, Georgia, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Washington University

St Louis, Missouri, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Vidant Medical Center

Greenville, North Carolina, United States

Lehigh Valley Hospital Center

Allentown, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Palmetto Health Richland

Columbia, South Carolina, United States

St Joseph Regional Health Center

Bryan, Texas, United States

University of Texas - Southwestern

Dallas, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Scott & White Hospital

Temple, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Marshall Health

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

BTG-PR005-002

Identifier Type: -

Identifier Source: org_study_id