Your session is about to expire
← Back to Search
Phospholipase A2 Inhibitor
Varespladib for Snake Bites (BRAVIO Trial)
Phase 2
Recruiting
Led By Timothy Platts-Mills, MD, MSc
Research Sponsored by Ophirex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 and 6 hours
Awards & highlights
BRAVIO Trial Summary
This trial will study if an IV and oral drug combo can help people bitten by venomous snakes, and if it's safe and effective.
Who is the study for?
Adults (18+) with a venomous snakebite within the last 10 hours can join this trial. They must have certain symptoms measured by an inclusion score and agree to informed consent. People with severe heart, bleeding, or liver conditions, kidney disease, allergies to varespladib, on certain anticoagulants or antiarrhythmics recently, pregnant or breastfeeding women cannot participate.Check my eligibility
What is being tested?
The BRAVIO study is testing IV varespladib followed by oral varespladib-methyl against placebos in addition to standard care for snakebites. It's a phase 2 trial where participants are randomly assigned treatments in a double-blind manner so neither they nor the researchers know who gets what.See study design
What are the potential side effects?
Potential side effects of varespladib may include reactions at the infusion site for IV form and gastrointestinal issues like nausea for oral form. Since it's under study, there might be unknown risks as well.
BRAVIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 and 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 and 6 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the curve of the composite outcome of the pulmonary, cardiovascular, local wound, hematologic, renal and nervous system sections of the snakebite severity score (SSS) from Baseline (pre-dosing) to Day 7.
Secondary outcome measures
All-cause mortality at Day 28
Area under the curve of the composite outcome of pulmonary, cardiovascular, local wound, hematologic, renal, and nervous system sections of the SSS from Baseline to Day 7, among patients receiving study drug, 6 hours after bite or symptom onset
Change in the composite outcome of pulmonary, cardiovascular, hematologic, renal, and nervous system sections of the SSS from Baseline to the average of the scores 3 and 6 hours after the first dose.
+17 moreBRAVIO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOCExperimental Treatment2 Interventions
Participants will receive intravenous (IV) infusion of varespladib at dose of 0.45 milligrams per kilogram per hour (mg/kg/hr) for six hours. This infusion will continue until when the participant meets clinical criteria for transition to oral drug, -If criteria are met, they will be transitioned to varespladib-methyl (initial dose of 500 mg) then continued oral dosing q12 (once every 12 hours) of 250 mg for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion at 0.45 mg/kg/hr (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug.
Group II: Placebo Intravenous (IV) + Placebo Oral + SOCActive Control2 Interventions
Participants will receive intravenous (IV) infusion of placebo matched to varespladib for six hours. This infusion will continue until the participant meets clinical criteria for transition to oral drug. If criteria are met, they will be transitioned to the oral placebo then continued oral dosing for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug.
Find a Location
Who is running the clinical trial?
Ophirex, Inc.Lead Sponsor
2 Previous Clinical Trials
114 Total Patients Enrolled
1 Trials studying Snake Bites
96 Patients Enrolled for Snake Bites
Timothy Platts-Mills, MD, MScPrincipal InvestigatorOphirex, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of chronic liver disease.I was bitten by a Russell's viper or krait in India.This criterion does not apply to me.I have had a stroke, bleeding in the brain, heart attack, or severe lung blood pressure.I was bitten by a snake and have moderate to severe muscle weakness.I have been bitten by a snake that may be venomous.I am 18 or older and was bitten by a venomous snake.I have kidney problems or chronic kidney disease.I have a genetic condition that affects my blood's ability to clot.I am currently taking or have recently taken blood thinners or drugs for irregular heartbeat.I was bitten by a venomous snake less than 5 hours ago and have symptoms affecting more than one part of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC
- Group 2: Placebo Intravenous (IV) + Placebo Oral + SOC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most comprehensive level of enrollment in this experiment?
"Ophirex Inc. seeks to enrol 110 qualified individuals for their clinical trial, which will be held in the Desert Regional Medical Center of Palm Springs, California and Antelope Valley Medical Centre of Rosamond Kentucky."
Answered by AI
What potential risks do patients incur when taking Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC?
"While there is minimal evidence of its efficacy, the safety profile of Varespladib IV in conjunction with SOC and oral tablets (LY315920) has been rated a 2 due to multiple rounds of data supporting its security."
Answered by AI
Are there multiple locations conducting this research within the state?
"Those eligible for this clinical trial can be enrolled at Desert Regional Medical Center, Antelope Valley Medical Centre and Emergency Medicine University of Kentucky. Additionally, there are 6 more sites available to interested participants spread across the US."
Answered by AI
Are there vacancies in this research endeavor for participants?
"Affirmative, the details on clinicaltrials.gov verify that this medical trial has commenced recruitment of participants. It was initially posted 30th May 2023 and latest updates were released 7th June 2021; aiming to have 110 individuals from 6 different sites join the study."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger