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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.
Egaten (Triclabendazole) 250 mg tablets
Not yet recruiting
Published on BioPortfolio: 2020-01-22T12:12:55-0500
WHO considers foodborne trematodes as neglected tropical diseases. Fascioliasis is the most widely distributed trematode reported from over 81 countries around the world it imposes its hig...
Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and phar...
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Fascioliasis is a neglected zoonosis with major public health implications in humans. Although triclabendazole (TCBZ) is the drug of choice, there are records of TCBZ failure worldwide. TCBZ-resistant...
The prevalence of fascioliasis in a population of cattle in a new-emerging focus of human fascioliasis in Boyer-Ahmad District, in the southwest of Iran, was investigated, using an ELISA system and co...
We report 2 cases of human fascioliasis (HF) in Belgium, likely caused by consumption of vegetables from a garden that was flooded by pasture runoff. Because autochthonous HF is rare and the route of ...
Fascioliasis is one of the most important food-borne worm disease caused by sp. Parasitological diagnosis is more difficult due to the low parasite burden and a few eggs shedding of helminths. Theref...
Fascioliasis is a food-borne anthropozoonotic disease caused by Fasciola hepatica that affects multiple hosts, including humans. We herein report the first case of human fascioliasis in the state of S...
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Liver disease caused by infections with parasitic flukes of the genus FASCIOLA, such as FASCIOLA HEPATICA.
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Novartis is the fourth largest pharmaceutical company in the world, based on annual sales, which are exceeded $36,000m in 2009. Founded in 1996, Novartis focuses of four main areas; pharmaceuticals, vaccines & diagnostics, generic medicines and biosi...