Health Condition 1: T630- Toxic effect of snake venom
Conditions
Interventions
Intervention1: Varespladib-Methyl / Placebo: Varespladib-Methyl:
Tablet: Varespladib-methyl (LY333013) formulated as an immediate-release, white film-coated oval tablet (250 mg).
Capsule: Varespladib
Sponsors
Ophirex Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Is a male or female >= 5 years of age with venomous snakebite and a qualifying SSS inclusion score. SSS inclusion categories are: local wound, pulmonary, cardiovascular, hematologic, and nervous system. Hematologic score may be counted if available, but inclusion should not wait for laboratory results. GI or Renal categories will not count for inclusion. A qualifying SSS inclusion score may be either: 2 points in any single SSS inclusion category AND at least 1 point in any other SSS inclusion category OR >= 3 in any single SSS inclusion category 2. Index event (snakebite) must be symptomatic and must have occurred within 8 hours of eligibility assessment. 3. Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
Exclusion criteria
Exclusion criteria: 1. Has received antivenom treatment for envenoming prior to enrollment in this study. 2. Has an upper gastrointestinal (GI) bleed evidenced by hematemesis, â??coffee-groundâ?? emesis or nasogastric spirate, or hematochezia thought to originate from upper GI tract. 3. Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension. 4. Has known history of inherited bleeding or coagulation disorder. 5. 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 antiarrhythmic drugs within 14 days prior to treatment. 6. 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. 7. Has chronic kidney disease (defined as Stage 4 or receiving dialysis) or acute renal insufficiency with an eGFR 8. Has a known allergy or significant adverse reaction to varespladib-methyl or related compounds. 9. Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of the snakebite severity score (SSS) from Baseline (pre-dosing) to 6 hours after first doseTimepoint: 6 hours after first dose | — |
Secondary
| Measure | Time frame |
|---|---|
| SSS(pre-dosing) and PGIC from Baseline to Day7 after 1dose Coagulation abnormalities in patients with SSS hematology score of â?¥2 at Baseline to Day7 Hemolysis markers in patients with gross hemolysis at Baseline to Day3 Levels of the myonecrosis marker,CK in patients withâ?¥2x institutional reference range at Baseline toDay3 Total differential antivenom requirement, duration of ventilatory support, ICU stay, hospitalization through Day28 along with all cause mortality and PSFS total score Timepoint: Day 28 | — |
Countries
India, United States of America
Contacts
Public ContactMr Bhavesh Acharya
Ophirex Inc.
Outcome results
None listed