[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652292":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":58,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":24,"enrollmentInfo":71,"targetDuration":24,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HCV patients with GFR more than 30ml\u002Fmin","ACTIVE_COMPARATOR","25 CKD Patients with eGFR˃30ml\u002Fmin with HCV infection and will receive one oral tablet of Sofosbuvir 400mg\u002Fday and one oral tablet of Daclatasvir 60mg\u002Fday for 12 weeks.",[13],"Drug: SOF+DCV",{"label":15,"type":10,"description":16,"interventionNames":17},"HCV patients withGFR less than 30ml\u002Fmin","25 CKD Patients with eGFR≤30ml\u002Fmin with HCV infection and will receive 2 oral tablets Qurevo®\u002Fday (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks.",[18],"Drug: OBV\u002FPTV\u002Fr) ± ribavirin (RBV)",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","SOF+DCV",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"OBV\u002FPTV\u002Fr) ± ribavirin (RBV)",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Ahmed El Gammalh, Bsc in pharmaceutical sciences","CONTACT","+201128907433","dr_ahmed_k658@yahoo.com",[35],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee","Tanta","Gharbia Governorate","31719","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],31.00192,30.78847,{"lat":46,"lon":45},[49,53,55],{"name":50,"role":31,"phone":51,"phoneExt":24,"email":52},"Viral committee Tanta University","+20403337544","dean@med.tanta.edu.eg",{"name":24,"role":31,"phone":24,"phoneExt":24,"email":54},"dr.ahmed.k658@gmail.com",{"name":56,"role":57,"phone":24,"phoneExt":24,"email":24},"Ahmed Gamal El Gammalh, Pharmacist","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ahmed Gamal Mohamed El Gammalh","Principal investigator","100652292","phase-2-treatment-of-ckd-patients-with-hcv-100652292",false,"NCT07770984","Treatment of CKD Patients With HCV","Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV","HCV\u002FCKD","Inclusion Criteria:\n\n1. Both male and female.\n2. Adults more than 18 years.\n3. Patients with CKD different stages stable on treatment with or without HD.\n4. HD Patients should be stable for at least 6 months under regular hemodialysis.\n5. Clinically stable condition as outpatients.\n6. Patients with HCV infections (serum positive for HCV GT4 with HCV RNA\\>1000 IU\u002Fml by PCR).\n7. White blood cells count more than 2500\u002Fmm3.\n8. Platelet count more than 7500\u002Fmm3.\n\nExclusion Criteria:\n\n1. Confirmed pregnancy.\n2. HCV-HIV co infection.\n3. HBV-HCV co infection.\n4. Unstable CKD patients.\n5. Patients who are recently stabilized on HD (less than 6 months).\n6. Patients on peritoneal dialysis.\n7. For patients without cirrhosis, Patients will be excluded if ALT or AST more than five times the upper limit of normal.\n8. For patients with cirrhosis, Patients will be excluded if ALT or AST are higher than seven times the upper limit of normal.","ALL","18 Years",{"count":72,"type":73},50,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are:\n\noutcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels.\n\noutcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment.\n\nIf there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health.\n\nParticipants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml\u002Fmin with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml\u002Fmin with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.",[80],"HCV Infection ( Genotype 4) in CKD Patients",[82],"CKD\u002FHCV","NOT_YET_RECRUITING","2026-08-18",{"date":86,"type":87},"2026-08-20","ACTUAL",{"date":89,"type":73},"2026-09-15",{"date":91,"type":73},"2027-05-15",{"name":5,"class":6},1]