[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amivas Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100581659","phase-2-study-evaluating-the-efficacy-and-safety-of-artesunate-100581659",false,"NCT06853184","Study Evaluating the Efficacy and Safety of Artesunate","Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients","Inclusion Criteria:\n\n* Be at least 18 years of age\n* Recipient of a solid organ transplant (kidney, lung, heart, or liver)\n* Have a documented CMV infection\n* Have CMV DNAemia\n* Require IV GCV or oral VGCV\n* Be washed out from any anti-CMV antiviral drugs\n* Have all the following results as part of screening laboratory assessments\n* Have life expectancy of ≥ 12 weeks\n* Be willing and have an understanding and ability to fully comply with the study\n* If female use birth control\n\nExclusion Criteria:\n\n* Have taken IV GCV or oral VGC daily for \\>8 days\n* Have refractory CMV infection or disease\n* Have CMV antiviral drug resistance\n* Have a known hypersensitivity to artesunate, GCV, or VGCV\n* Pregnant (or expecting to conceive) or nursing\n* Have severe liver disease\n* Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV\n* Taking any another investigational drug with anti-CMV activity","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.",[26],"CMV Infection",[28],"CMV infection","RECRUITING","2026-05-18",{"date":32,"type":33},"2026-05-19","ACTUAL",{"date":35,"type":33},"2025-08-01",{"date":37,"type":20},"2028-06-30",{"name":39,"class":40},"Amivas Inc.","INDUSTRY",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100558798","evaluation-of-artesunate-in-infants-being-treated-for-severe-malaria-100558798","NCT06555809","Evaluation of Artesunate in Infants Being Treated for Severe Malaria","Pharmacokinetic Evaluation of Artesunate in Infants Being Treated for Severe Malaria - Research Laboratory Addendum to the Observational Study Titled: Safety and Efficacy of Artesunate in Pregnant Women and Infants (\u003C One Month of Age)","Inclusion Criteria:\n\n* Parental consent provided to the ARTEMUM Study\n* Parental consent provided to participate in this PK Laboratory Study\n* Infants \\\u003C 2 years of age with malaria (positive blood by polymerase chain reaction (PCR) or thin or thick smear or rapid diagnostic test (RDT), or any combination of those) treated by at least 1 dose of intravenous artesunate\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C 7.0 g\u002FdL at the time when additional blood sample for PK assessment will be drawn as part of standard of care","1 Minute","23 Months",{"count":52,"type":20},15,"OBSERVATIONAL","This is essentially a laboratory study that is an addendum to an ongoing prospective Phase 4 multicenter observational study titled: \"Safety and Efficacy of Artesunate in Pregnant Women and Infants (ARTEMUM)\" being conducted in France. Infants, the parents of whom provided consent to have data collected from their child as part of the ARTEMUM study, will have an additional blood sample collected when other standard of care blood specimens are collected during the 2-day period after the start of intravenous (IV) artesunate treatment. A maximum of 4 samples will be taken and plasma will be isolated and stored frozen until analysis for plasma artesunate and dihydroartemisinin (DHA) concentrations. Red blood cells will also be frozen for further analysis (for example Kelch-13 mutations). In addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests.",[56],"Malaria",[58,59],"Artesunate","Infant","2024-12-05",{"date":62,"type":33},"2024-12-10",{"date":64,"type":33},"2024-10-06",{"date":66,"type":20},"2030-02-28",{"name":39,"class":40},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":80,"studyType":53,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":68},"100461215","observational-study-of-the-safety-of-intravenous-artesunate-treatment-of-pregnant-women-and-their-infants-100461215","NCT05285735","Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants","Inclusion Criteria:\n\n* Patient received IV Artesunate\n* Patient was pregnant while receiving IV Artesunate\n* Patient was at least 15 years of age\n* Patient or legal guardian\u002Frepresentative gave consent for the study and to collect data from her physicians\n\nExclusion Criteria\n\n• None","FEMALE","15 Years","100 Years",{"count":79,"type":20},25,"21 Months","This study is a prospective observational study in which a female patient who received IV Artesunate while pregnant can volunteer to provide information about her pregnancy and the outcome of her pregnancy. Information will be collected from patient's provider, the patient's obstetrician, the child's pediatrician, or other relevant healthcare provider.",[83,56],"Pregnancy",[58,85],"Pregnancy Registry","2024-01-29",{"date":88,"type":33},"2024-01-30",{"date":90,"type":33},"2022-06-08",{"date":92,"type":20},"2029-07-01",{"name":39,"class":40},""]