[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544321":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":48,"locations":36,"responsibleParty":56,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":36,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":36,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":36,"overallStatus":83,"whyStopped":36,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":36},{"fullName":5,"class":6},"Universidad Peruana Cayetano Heredia","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxfendazole single dose","EXPERIMENTAL","Oxfendazole 100 mg capsules at 20 mg\u002Fkg of body weight as a single oral dose administered with a lipid containing meal under direct observation.",[13],"Drug: Oxfendazole",{"label":15,"type":10,"description":16,"interventionNames":17},"Oxfendazole two doses","Oxfendazole 100 mg capsules at 20 mg\u002Fkg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Triclabendazole","ACTIVE_COMPARATOR","Triclabendazole 250 mg tablets at 10 mg\u002Fkg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.",[23],"Drug: Triclabendazole",[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Oxfendazole","Human studies have shown that doses up to 60 mg\u002Fkg (approximately 3.6 g for a 60-kg human, which is considered the average weight of an adult in developing countries) are safe and that repeated doses of 15 mg\u002Fkg (approximately 900 mg for a 60-kg human) daily for 5 days are safe. A single dose of OXF results in significant plasma drug concentrations that reach a Cmax plateau after doses of 15 mg\u002Fkg.75 The dose to be studied in this trial is 20 mg\u002Fkg (1200 mg maximum dose), a dose only slightly higher than that achieving a Cmax plateau. This dose was conservatively selected to account for interindividual variation in plasma levels and deemed well tolerated and safe based on laboratory and ECG evaluations.",[9,15],[31,32],"Fenbendazole sulfoxide","Synanthic",{"type":26,"name":19,"description":34,"armGroupLabels":35,"otherNames":36},"The standard of care for the treatment of fascioliasis according to the same guidelines is two 10 mg\u002Fkg doses of TCBZ 24 hours apart administered with a fat containing meal. The subjects in one of the arms of the study will receive this treatment as the standard of care. Subjects from any of the arms that fail to achieve parasitological cure will receive rescue treatment off the study with two doses of TCBZ as recommended by the Peruvian guidelines.",[19],null,[38,42,46],{"name":39,"affiliation":40,"role":41},"Miguel M Cabada, MD MSc","University of Texas","STUDY_CHAIR",{"name":43,"affiliation":44,"role":45},"Lourdes Rodriguez, MD","Asociacion CerviCusco","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":5,"role":41},"Hector H Garcia, MD PhD",[49,53],{"name":39,"role":50,"phone":51,"phoneExt":36,"email":52},"CONTACT","+1 409 747 0236","micabada@utmb.edu",{"name":47,"role":50,"phone":54,"phoneExt":36,"email":55},"(511) 328-7360","hgarcia1@jhu.edu",{"type":57,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[59,62],{"name":60,"class":61},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":63,"class":6},"Oxfendazole Development Group","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":75,"type":76},336,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Fascioliasis","NOT_YET_RECRUITING","2026-06-01",{"date":86,"type":87},"2026-06-03","ACTUAL",{"date":89,"type":76},"2026-08-15",{"date":91,"type":76},"2029-04-15",{"name":5,"class":6}]