[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650974":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":61,"collaborators":65,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":101,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Annual treatment (standard) with Praziquantel","Treatment with praziquantel once per year (standard recommendation)",[12],"Drug: Praziquantel 40 mg\u002Fkg per dose given once annually",{"label":14,"type":15,"description":16,"interventionNames":17},"Treatment with Praziquantel three times per year","EXPERIMENTAL","Treatment with praziquantel three times per year (enhanced frequency)",[18],"Drug: Praziquantel 40 mg\u002Fkg given three times per year",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Praziquantel 40 mg\u002Fkg per dose given once annually","Standard recommended by World Health Organization (annual treatment)",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Praziquantel 40 mg\u002Fkg given three times per year","This intervention provides Praziquantel treatment three times per year (enhanced frequency compared to current WHO guidelines)",[14],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jennifer F Friedman, MD, PhD","CONTACT","401 444 7990","jennifer_Friedman@Brown.edu",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Haiwei W Wu, MD, PhD","401 444 7339","Haiwei_wu@Brown.edu",[41],{"facility":42,"status":25,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Uganda Virus Research Institute","Entebbe","Uganda","UG",{"type":47,"coordinates":48},"Point",[49,50],32.47949,0.05621,{"lat":50,"lon":49},[53,57],{"name":54,"role":33,"phone":55,"phoneExt":25,"email":56},"Andrew Edielu, MD, PhD","256750766037","aedielu@uvri.go.ug",{"name":58,"role":33,"phone":59,"phoneExt":25,"email":60},"Alison Elliott, MD","256-414-320385","Alison.Elliott@lshtm.ac.uk",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jennifer Friedman, MD, PhD","Director, Center for International Health Research & Professor of Pediatrics",[66,69],{"name":67,"class":68},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":70,"class":6},"MRC\u002FUVRI and LSHTM Uganda Research Unit","100650974","different-treatment-frequencies-for-hepatic-fibrosis-due-to-schistosomiasis-an-rct-100650974",false,"NCT07754617","Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis","An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis","SchiFT","Inclusion Criteria:\n\n1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA)\n2. Otherwise healthy as determined by history and physical examination conducted by the study clinician\n3. Not Pregnant\n4. Age 15-40 years\n5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years.\n6. The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below.\n\nExclusion Criteria:\n\n1. . History of upper gastrointestinal bleeding\n2. Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test\n3. Known neurocysticercosis or ocular cysticercosis","ALL","15 Years","40 Years",{"count":83,"type":84},600,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE2","PHASE3","The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are:\n\n1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years.\n2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years.\n3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens.\n\nParticipants will:\n\nBe screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial\n\nIf they are in the trial they will:\n\nTake the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year",[91,92,93,94],"Schistosomiasis","Schistosoma Mansoni","Liver Fibrosis","Portal Hypertension",[96,97,98,99,100],"schistosomiasis","schistosome mansoni","hepatic fibrosis","liver fibrosis","portal hypertension","NOT_YET_RECRUITING","2026-08-07",{"date":104,"type":105},"2026-08-12","ACTUAL",{"date":107,"type":84},"2026-11",{"date":109,"type":84},"2029-11",{"name":5,"class":6},1]