PER-058-20尚未招募未知
A PHASE IV, MULTI-CENTER, OPEN-LABEL STUDY TO DETERMINE THESAFETY, TOLERABILITY AND CLINICAL OUTCOMES FOLLOWING ORALADMINISTRATION OF EGATEN™ (TRICLABENDAZOLE) IN PATIENTS(6 YEARS OF AGE OR OLDER) WITH FASCIOLIASIS
ovartis Pharma AG.,0 个研究点目标入组 0 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Written informed consent must be obtained before any study protocol
- •specific assessment is performed.
- •a. 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.
- •b. Subjects < 18 years old, who are capable of providing
- •assent, must provide assent with parental/legal guardian
- •consent or as per local ethical guidelines.
- •c. 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.
- •2. 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.).
- •2. Subjects with known hypersensitivity to triclabendazole /other
- •benzimidazole derivatives and/or any of the excipients in Egaten
- •3. Subjects taking any anthelmintic medications within two weeks or 5
- •half-lives, whichever is longer prior to enrolling into study.
- •4. Inability or unwillingness to undergo study related procedures.
- •5. 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
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