Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)

Completed · Phase 2 · Has a placebo group

Conditions studied: Snakebite, Envenoming, Snake

In brief

This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD

Key facts

Study ID

NCT05717062

Run by

Ophirex, Inc.

People needed

140

Starts

2023-05-30

Expected to finish

2025-02-24

Last updated by the study team

2025-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a male or female ≥ 18 years of age with venomous snakebite.
• Patients must have known or suspected venomous snakebite. In India, enrollment will be restricted to patients bitten by suspected or confirmed Russell's viper (Daboia russelii) or krait (Bungarus spp.) In the U.S., any snakebite that meets all other criteria may be eligible.
• Participants must meet one of two categories of inclusion criteria:
• Category 1: The participant is enrolled within 5 hours of venomous snakebite or symptom onset with an SSS score of ≥2 in one system and ≥1 in another system (2+1).
• OR
• Category 2: The participant has a suspected or confirmed bite from an elapid and is enrolled within 10 hours of bite or symptom onset with moderate to severe cranial nerve or skeletal muscle weakness.
• Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.

You may not qualify if…

• Has history of or is suspected to have CVA or intracranial bleeding of any kind, acute coronary syndrome, MI, or severe pulmonary hypertension.
• Has known history of inherited bleeding or coagulation disorder.
• Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin, argatroban, bilvalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel, ticlodipine or another anticoagulant agent not specifically listed, or has used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or any antiarrhythmic drugs within 14 days prior to treatment.
• Has a history of chronic liver disease such as chronic active viral hepatitis, alcohol- related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis.
• Reports or has known pre-existing renal impairment or chronic kidney disease.
• Has a known allergy or significant adverse reaction to varespladib or varespladib-methyl.
• Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns.
• Is pregnant, has a positive serum human chorionic gonadotropin (hCG) pregnancy test or not willing to use a highly effective method of contraception for 14 days after initial treatment, or is breast-feeding.

Where it is running

• Banner University Medical Center - Phoenix — Phoenix, Arizona, United States
• Arizona Poison & Drug Information Center — Tucson, Arizona, United States
• Desert Regional Medical Center — Palm Springs, California, United States
• Antelope Valley Medical Center — Rosamond, California, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• University of South Florida/Tampa General Hospital — Tampa, Florida, United States
• Emergency Medicine, University of Kentucky — Lexington, Kentucky, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Texas Tech University Health Sciences Center El Paso — El Paso, Texas, United States
• UT Health San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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