Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).

Launched by NOVARTIS PHARMACEUTICALS · Jan 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Egaten for treating fascioliasis, an infection caused by a type of flatworm. The trial involves about 300 patients aged 6 years and older, both adults and children, who have been diagnosed with either acute or chronic fascioliasis. Participants will receive two doses of Egaten, taken 12 hours apart, and will be monitored closely for any side effects and how well the treatment works over several follow-up visits.

To be eligible for the trial, participants must be at least 6 years old and weigh more than 12.5 kg, and they need to provide informed consent (or have a parent or guardian do so for younger participants). However, some individuals, such as those with certain medical conditions or those who are pregnant or breastfeeding, may not qualify. Throughout the study, participants will have various follow-up appointments to ensure their safety and to assess the treatment's effectiveness. This is an important opportunity for individuals suffering from fascioliasis to potentially benefit from a new treatment while contributing to medical research.

Gender

ALL

Eligibility criteria

• 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 (formally documented and witnessed, via an independent trusted witness) 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.