[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fascioliasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fascioliasis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100544321","phase-2-one-and-two-doses-of-oxfendazole-versus-a-schedule-of-two-doses-of-triclabendazole-in-chronic-fascioliasis-100544321",false,"NCT06367361","One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis","A Non-Inferiority, Randomized, Blind Laboratory Analysis, Controlled Trial Comparing One and Two Doses Regimes of Oxfendazole Versus a Two Dose Regime of Triclabendazole to Treat Chronic Fascioliasis","Inclusion Criteria:\n\n1. Male and female subjects eighteen years or older with positive stool microscopy and\u002For egg counts confirmed by qualitative and\u002For quantitative stool microscopy performed within the past 14 days.\n2. Subjects capable of understanding the informed consent process and providing written informed consent.\n3. Willingness to give informed consent.\n\nExclusion Criteria:\n\n1. Subjects reporting previous treatment for fascioliasis\n2. Subjects with a stool egg count \\> 300 eggs\u002Fg in stool samples\n3. Women with a positive urine pregnancy test or planning to become pregnant\n4. Women that are nursing\n5. Alanine aminotransferase (ALT) ≥ 3 or Aspartate aminotransferase (AST) ≥ 3 times above the upper limit of normal within 14 days before enrollment.\n6. Subjects with active cerebral cysticercosis determined by serology and imaging studies\n7. Subjects with known liver disease, liver cirrhosis, or end stage renal disease\n8. Subjects with known allergy or AEs to benzimidazole drugs\n9. Subjects taking carbamazepine, phenobarbital, phenytoin, or other medication known to decrease the serum concentrations of benzimidazoles.\n10. Women unable or unwilling to use an acceptable birth control method.\n11. Male volunteers who are unwilling to ensure pregnancy prevention in their partner.\n12. Volunteers with a previously recorded electrocardiogram showing heart-rate corrected (QTc) prolongation, or who are taking medications associates with heart-rate corrected (QTc) prolongation, such as selective serotonin reuptake inhibitors, quinolones, or macrolides.\n13. Volunteers with acute fascioliasis.\n14. Volunteers who fail to demonstrate adequate understanding of the study after three attempts.","ALL","18 Years","65 Years",{"count":20,"type":21},336,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg\u002Fkg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg\u002Fkg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.",[27],"Fascioliasis","NOT_YET_RECRUITING","2026-06-01",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":21},"2026-08-15",{"date":36,"type":21},"2029-04-15",{"name":38,"class":39},"Universidad Peruana Cayetano Heredia","OTHER"]