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NCT07811908
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Conditions: Uncomplicated Plasmodium Falciparum Malaria
Sex: All
Ages: 2 Years – 12 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Banfora
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Male and female participants 2 to \ 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
* AST/ALT \> 1.5 and ≤ 2 x ULN and total bilirubin is \> ULN
* Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
4. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
* Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
* History of familial long QT syndrome or known family history of Torsades de Pointe.
* Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm
Other protocol-defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07811908). StuddyBuddy aggregates publicly available trial information.