Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Varespladib Followed by Oral Varespladib in Addition to Standard of Care in Subjects Bitten by Venomous Snakes. - OPX-PR-03

Ophirex, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

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•1. Is a male or female greater than or equal to 18 years of age with venomous snakebite.
•2. Index event (snakebite) must be symptomatic and symptom onset must have occurred within 10 hours of eligibility assessment.
•3. Patients must meet one of two categories of inclusion criteria: Category 1: The patient has not yet completed first dose of antivenom: SSS inclusion score of greater than or equal to 2 in one system and greater than or equal to 1 in another system i.e 2+1 OR greater than or equal to 3 in at least one system. OR Category 2: The patient has completed an initial dose of antivenom: SSS inclusion score of greater than or equal to 2 in one system and greater than or equal to 1 in another system i.e 2+1 OR greater than or equal to 3 in at least one system AND CGI-I score of greater than or equal to 5 i.e., minimally worse, much worse, or very much worse.
•4. Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
•Only local wound, pulmonary, cardiovascular, hematologic, or nervous system scores qualify for SSS inclusion criteria. GI and Renal scores are not used for inclusion. Hematologic score may be counted if available, but inclusion should not wait for laboratory results. Point of care tests e.g., 20WBCT, may be used for enrollment, if used per site standard of care.

•1. Has history of or is suspected to have cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
•2. Has known history of inherited bleeding or coagulation disorder.
•3. 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.
•4. 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.
•5. Reports or has known pre-existing renal impairment or chronic kidney disease.
•6. Has a known allergy or significant adverse reaction to varespladib or varespladib-methyl.
•7. Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns.
•8. Is pregnant, has a positive urine or 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 breastfeeding.

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