CTRI/2021/11/037901已完成2 期
Randomized, Double-Blinded, Placebo-Controlled Add-On Therapy Study to Evaluate the Safety, Tolerability, and Efficacy of a Multi-Dose Regimen of Oral Varespladib-Methyl in Subjects Bitten by Venomous Snakes
Ophirex Inc8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年1月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Area under the curve (AUC) of the snakebite severity score (SSS) from Baseline (pre-dosing) to 6 hours after first dose
研究概览
简要总结
A study is Randomized, Double-Blinded, Placebo-Controlled Add-On Therapy to Evaluate the Safety, Tolerability, and Efficacy of a Multi-Dose Regimen of Oral Varespladib Methyl in Subjects Bitten by Venomous Snakes (BRAVO study - Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Index event (snakebite) must be symptomatic and must have occurred within 8 hours of eligibility assessment.
- •Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
排除标准
- •Has received antivenom treatment for envenoming prior to enrollment in this study.
- •Has an upper gastrointestinal (GI) bleed evidenced by hematemesis, “coffee-ground†emesis or nasogastric spirate, or hematochezia thought to originate from upper GI tract.
- •Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, 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 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.
- •Has chronic kidney disease (defined as Stage 4 or receiving dialysis) or acute renal insufficiency with an eGFR < 60 mL/min (including patients receiving hemodialysis or hemofiltration).
- •Has a known allergy or significant adverse reaction to varespladib-methyl or related compounds.
- •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.
结局指标
主要结局
Area under the curve (AUC) of the snakebite severity score (SSS) from Baseline (pre-dosing) to 6 hours after first dose
时间窗: 6 hours after first dose
次要结局
- SSS(pre-dosing) and PGIC from Baseline to Day7 after 1dose(Coagulation abnormalities in patients with SSS hematology score of ≥2 at Baseline to Day7)
研究者
研究点 (8)
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