A Phase IV, Multi-center, Open-label Study to Determine the Safety, Tolerability and Clinical Outcomes Following Oral Administration of EGATEN™ (Triclabendazole) in Patients (6 Years of Age or Older) With Fascioliasis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 11
- 主要终点
- Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths
研究概览
简要总结
This is a multicenter, open label, non-comparative, single arm multi-country study in approximately 300 adult and pediatric subjects (≥ 6 years of age) with fascioliasis. The study population consists of male and female adult and pediatric patients (≥ 6 years of age). The study will enroll approximately 300 subjects with acute (minimum 15% of overall study population) or chronic fascioliasis. Enrolled subjects will receive two doses of 10 mg/kg of Egaten given approximately 12 hours apart. Subjects will be treated and followed up on an outpatient basis. After screening and post treatment, at Day 3 and Day 6 the subjects will be followed for safety and tolerability. These visits are primarily for safety follow up and may be telephonic or home visit by qualified personnel or onsite visits based on the investigator's discretion. During visits Day 10, Day 30, Day 60 and Day 90 post-treatment, the subjects will be followed for safety, tolerability and efficacy. On Day 15, Day 45 and Day 75, telephonic follow-up (primarily for safety) will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any study protocol specific assessment is performed.
- •Parental/legal guardian informed consent must be obtained and signed for pediatric subjects (formally documented and witnessed, via an independent trusted witness) prior to any study related procedure.
- •Subjects < 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines.
- •If the subject is unable to read and write or otherwise incapable of signing an informed consent, then a witnessed consent according to local ethical standards is permitted.
- •Subjects (Adult and pediatric subjects ≥ 6 years of age and above 12.5 kg of weight) at time of consenting must have been diagnosed with fascioliasis based on clinical signs, symptoms and laboratory evaluations as per local clinical practice.
排除标准
- •Subjects diagnosed with ectopic fascioliasis, extrahepatic involvement (e.g., lungs, spleen, pancreas, subcutaneous tissue, gastrointestinal organs, etc.).
- •Subjects with known hypersensitivity to triclabendazole /other benzimidazole derivatives and/or any of the excipients in Egaten.
- •Subjects taking any anthelmintic medications within two weeks or 5 half-lives, whichever is longer prior to enrolling into study.
- •Inability or unwillingness to undergo study related procedures.
- •Subjects who in the judgment of the Clinical Investigator are unsuitable for the trial or who have to be excluded in order to be compliant with local fascioliasis management guidelines that may differ from the FDA approved label, including but not limited to :
- •Subjects who are machine operators or drivers.
- •Medical history of liver (other than fascioliasis), kidney or cardiac disease.
- •Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.
- •Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.
- •Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin).
- •Subjects with medical history of QT prolongation or a history of symptoms compatible with a long QT interval or on medication which prolong the QT interval.
研究组 & 干预措施
Egaten
All subjects will receive Egaten as two 10 mg/kg doses given 12 hours apart.
干预措施: Egaten (Triclabendazole) 250 mg tablets (Drug)
结局指标
主要结局
Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths
时间窗: Day 90
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Egaten administered as two 10 mg/kg doses given 12 hours apart in subjects with Fascioliasis is safe through the monitoring of relevant clinical and laboratory safety parameters.
次要结局
- Clinical cure rate in Acute Fascioliasis subjects over time.(Day 10, Day 30, Day 60 and Day 90)
- Parasitological cure rate in Chronic Fascioliasis subjects over time.(Day 10, Day 30, Day 60 and Day 90)
- Clinical cure rate of Chronic Fascioliasis subjects over time.(Day 10, Day 30, Day 60 and Day 90)