[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655402":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":39,"armGroups":48,"interventions":62,"overallOfficials":39,"centralContacts":82,"locations":90,"responsibleParty":210,"collaborators":39,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":214,"sex":220,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":39,"studyType":226,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":93,"whyStopped":39,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)","ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).","Day 29",[14,18,21,25,27,29,31,33,35,37],{"measure":15,"description":16,"timeFrame":17},"Parasite clearance time (PCT)","To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria","up to Day 7",{"measure":19,"description":20,"timeFrame":12},"PCR-uncorrected ACPR","To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in participants with uncomplicated P. falciparum malaria.",{"measure":22,"description":23,"timeFrame":24},"Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)","To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.","Day 8",{"measure":26,"description":23,"timeFrame":24},"Maximum observed concentration (Cmax)",{"measure":28,"description":23,"timeFrame":24},"Time to reach maximum observed concentration (Tmax)",{"measure":30,"description":23,"timeFrame":24},"Elimination half-life (T1\u002F2)",{"measure":32,"description":23,"timeFrame":24},"Total body clearance (CL\u002FF)",{"measure":34,"description":23,"timeFrame":24},"Apparent volume of distribution (V\u002FF)",{"measure":36,"description":23,"timeFrame":24},"Area under the concentration-time curve from time zero to infinity (AUCinf)",{"measure":38,"description":23,"timeFrame":24},"Area under the concentration-time curve (AUC0-t)",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":39},"NONE","This study is open-label, but Core Clinical Team is blinded to treatment information.","The Cohort C2 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a single oral dose of up to three anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in children aged 2 to \\\u003C12 years.",[49,56],{"label":50,"type":51,"description":52,"interventionNames":53},"Cohort C2: KLU156 + KAE609","EXPERIMENTAL","KLU156 + KAE609 was administered orally with light meal.",[54,55],"Drug: KAE609","Drug: KLU156",{"label":57,"type":58,"description":59,"interventionNames":60},"Cohort C2: SoC (Artemether + lumefantrine)","ACTIVE_COMPARATOR","Artemether + lumefantrine 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4560","Rwanda","RW",{"type":98,"coordinates":188},[189,190],30.05885,-1.94995,{"lat":190,"lon":189},{"facility":92,"status":104,"city":193,"state":39,"zip":194,"country":195,"countryCode":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":39},"Kampala","101","Uganda","UG",{"type":98,"coordinates":198},[199,200],32.58219,0.31628,{"lat":200,"lon":199},{"facility":92,"status":104,"city":203,"state":39,"zip":204,"country":195,"countryCode":196,"cosmosGeoPoint":205,"geoPoint":209,"contacts":39},"Tororo","10102",{"type":98,"coordinates":206},[207,208],34.18085,0.69299,{"lat":208,"lon":207},{"type":211,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100655402","phase-2-platform-study-to-evaluate-the-efficacy-and-safety-of-anti-malarial-agents-in-participants-with-uncomplicated-plasmodium-falciparum-malaria-cohort-c2-100655402",false,"NCT07811908","Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)","A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and\u002For Combination Therapy IN Participants With Uncomplicated Plasmodium Falciparum Malaria","PLATINUM","Inclusion Criteria:\n\n1. Male and female participants 2 to \\\u003C12 years of age at screening.\n2. Participants must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 1,000 to 150,000 asexual parasite count\u002Fμl of blood for P. falciparum.\n3. Participants must weigh at least 10 kg at screening.\n\nExclusion Criteria:\n\n1. Participants with signs and symptoms of severe\u002Fcomplicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening\n2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \\\u003C 8 g\u002FdL), or known chronic underlying disease such as sickle cell disease at screening\n3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:\n\n   * AST\u002FALT \\> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin\n   * AST\u002FALT \\> 1.5 and ≤ 2 x ULN and total bilirubin is \\> ULN\n   * Total bilirubin \\> 2 x ULN, regardless of the level of AST\u002FALT\n4. Any known\u002Fsuspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.\n5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:\n\n   * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n   * History of familial long QT syndrome or known family history of Torsades de Pointe.\n   * Resting heart rate (physical exam or 12 lead ECG) \\\u003C 50 bpm\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","2 Years","12 Years",{"count":224,"type":225},120,"ESTIMATED","INTERVENTIONAL",[228],"PHASE2","This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.",[231],"Uncomplicated Plasmodium Falciparum Malaria",[233,234,235,236,218],"single dose cure malaria","uncomplicated malaria","Plasmodium falciparum","platform study","2026-09-04",{"date":239,"type":240},"2026-09-10","ACTUAL",{"date":242,"type":240},"2026-02-12",{"date":244,"type":225},"2027-02-18",{"name":84,"class":6},13]