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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
301
Egaten 250 mg scored tablets for oral use.
Novartis Investigative Site
Medellín, Antioquia, Colombia
Novartis Investigative Site
Alexandria, Egypt
Novartis Investigative Site
Cairo, Egypt
Novartis Investigative Site
San Martín de Porres, Lima region, Peru
Novartis Investigative Site
Cusco, Peru
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Gaziantep, Sehitkamil, Turkey (Türkiye)
Novartis Investigative Site
Sur, Turkey (Türkiye)
Novartis Investigative Site
Van, Turkey (Türkiye)
Novartis Investigative Site
Qui Nhon, Binh Dinh, Vietnam
Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths
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.
Time frame: Day 90
Clinical cure rate in Acute Fascioliasis subjects over time.
The clinical cure rate in Acute Fasciolisis subjects will be measured by the proportion of subjects with: 1. Resolution of baseline signs and symptoms. 2. Improvement in baseline laboratory parameters. 3. Improvement in baseline ultrasound findings.
Time frame: Day 10, Day 30, Day 60 and Day 90
Parasitological cure rate in Chronic Fascioliasis subjects over time.
The parasitological cure rate in Chronic Fascioliasis subjects will be measured by the proportion of subjects with absence of fasciola eggs confirmed by stool examination.
Time frame: Day 10, Day 30, Day 60 and Day 90
Clinical cure rate of Chronic Fascioliasis subjects over time.
The clinical cure rate in Chronic Fasciolisis subjects will be measured by the proportion of subjects with: 1. Resolution of baseline signs and symptoms. 2. Improvement in baseline laboratory parameters. 3. Improvement in baseline ultrasound findings.
Time frame: Day 10, Day 30, Day 60 and Day 90
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