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Egaten 在片形吸虫病患者（6 岁或以上）中的安全性、耐受性和临床结果研究。

2026年10月22日 更新者：Novartis Pharmaceuticals

一项 IV 期、多中心、开放标签研究，旨在确定片形吸虫病患者（6 岁或以上）口服 EGATEN™（三氯苯达唑）后的安全性、耐受性和临床结果。

The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age).

研究概览

地位

完全的

条件

干预/治疗

详细说明

This was an open-label, single-arm, multi-center multi-country, non-comparative study planned in adult and pediatric participants (≥ 6 years of age) with acute or chronic fascioliasis.

Screening/Baseline: Screening and baseline assessments were performed as per protocol.

Treatment phase: Enrolled participants were treated with two doses of 10 mg/kg triclabendazole given approximately 12 hours apart, with the first dose administered on Day 1 under site study team's supervision. The second dose was either taken at home (self-administered) or administered at the site.

Follow-up phase: Post-treatment at Day 3 and Day 6, the enrolled participants were followed for safety and tolerability. These visits were conducted by telephone, through home visits by qualified personnel, or through onsite visits, based on the investigator's discretion. During the post treatment study site visits at Day 10, Day 30, Day 60, and Day 90 (EOS visit), the enrolled participants were followed for safety, tolerability, and efficacy. On Day 15, Day 45, and Day 75, telephonic follow ups (primarily for safety) were conducted.

研究类型

介入性

注册 (实际的)

301

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 哥伦比亚
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、050010
        • Novartis Investigative Site
  • 土耳其（türkiye）
      • Sur、土耳其（türkiye）、21280
        • Novartis Investigative Site
      • Van、土耳其（türkiye）、65080
        • Novartis Investigative Site
    • Fatih
      • Istanbul、Fatih、土耳其（türkiye）、34093
        • Novartis Investigative Site
    • Sehitkamil
      • Gaziantep、Sehitkamil、土耳其（türkiye）、27310
        • Novartis Investigative Site
  • 埃及
      • Alexandria、埃及、21131
        • Novartis Investigative Site
    • Egypt
      • Cairo、Egypt、埃及、11617
        • Novartis Investigative Site
  • 秘鲁
      • Cusco、秘鲁、08002
        • Novartis Investigative Site
    • Lima region
      • San Martín de Porres、Lima region、秘鲁、15102
        • Novartis Investigative Site
  • 越南
    • Binh Dinh
      • Qui Nhon、Binh Dinh、越南、590000
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 99年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Written informed consent must be obtained before any study protocol specific assessment is performed.

    1. Parental/legal guardian informed consent must be obtained and signed for pediatric subjects prior to any study related procedure.
    2. Subjects < 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines.
    3. 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.

Exclusion Criteria:

  1. 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 :

    1. Subjects who are machine operators or drivers.
    2. Medical history of liver (other than fascioliasis), kidney or cardiac disease.

  6. Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.

  7. Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.

  8. Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin).

  9. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Egaten

Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food.
药品：Egaten (Triclabendazole) 250 mg tablets

Egaten 250 mg scored tablets for oral use.

其他名称：
  • 三氯苯达唑

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.

Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.

次要结果测量

结果测量
措施说明
大体时间
Percentage of Acute and Chronic Fascioliasis Participants Who Achieved Clinical Response
大体时间：Baseline, Day 10

Clinical Response at Day 10 was defined as improvement or resolution of baseline signs and symptoms.

95% confidence interval (CI) is calculated based on Clopper-Pearson method.
Baseline, Day 10
Percentage of Acute Fascioliasis Participants Who Achieved Clinical Cure
大体时间：Baseline, Day 30, Day 60 and Day 90

A participant was considered to achieve clinical cure if all of the following criteria were met.

  • Resolution of all sign and symptoms present at baseline
  • Improvement in ultrasound findings:

Abdomen - for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)

• Improvement in the lab parameter from baseline: Eosinophil count: ≥ 50% reduction from baseline value or reaching normal range if baseline value was above normal range

95% confidence interval (CI) is calculated based on Clopper-Pearson method.
Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Clinical Cure
大体时间：Baseline, Day 30, Day 60 and Day 90

A participant was considered to achieve clinical cure if all of the following criteria were met.

  • Resolution of all sign and symptoms present at baseline
  • Improvement in ultrasound findings: Abdomen - for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)
  • Improvement in the lab parameter from baseline:

Eosinophil count: ≥50% reduction from baseline or reaching normal range if baseline value was above normal range Hemoglobin: ≥1 g/dL increase from baseline value or reaching normal range if baseline value was below normal range Liver function test: ≥1 grade improvement from baseline or reaching normal range for each test if baseline value was above normal range Erythrocyte sedimentation rate: ≥ 50% reduction from baseline or reaching normal range if baseline value was above normal range

95% CI is calculated based on Clopper-Pearson method.
Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Parasitological Cure
大体时间：At Day 10, Day 30, Day 60 and Day 90

The parasitological cure rate in chronic fascioliasis participants was measured by the proportion of participants with absence of fasciola eggs confirmed by stool examination. In case of missing assessments at post baseline visits, parasitological cure is imputed as cured if two consecutive prior visits are negative, else parasitological cure is imputed as not cured. 95% confidence interval (CI) is calculated based on Clopper-Pearson method.
At Day 10, Day 30, Day 60 and Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

  • 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年2月11日

初级完成 (实际的)

2026年3月27日

研究完成 (实际的)

2026年3月27日

研究注册日期

首次提交

2020年1月14日

首先提交符合 QC 标准的

2020年1月14日

首次发布 (实际的)

2020年1月18日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年10月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CEGA230B2404

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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