NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)

NCT07811908

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Uncomplicated Plasmodium Falciparum Malaria

Interventions: KAE609, SoC (Coartem), KLU156

Countries: Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya, Rwanda, Uganda

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 overview

Sex: ALL

Age: 2 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Male and female participants 2 to \<12 years of age at screening.
2. 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/μl of blood for P. falciparum.
3. Participants must weigh at least 10 kg at screening.

Exclusion Criteria:

1. Participants with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
3. 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:

   * AST/ALT \> 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.
Locations (13)
  • Banfora, Burkina Faso
  • Nanoro, Burkina Faso
  • Abidjan, Côte d’Ivoire
  • Azaguié, Côte d’Ivoire
  • Lambaréné, Gabon
  • Libreville, Gabon
  • Kintampo, Ghana
  • Navrongo, Ghana
  • Ahero, Kenya
  • Kisumu, Kenya
  • Kigali, Rwanda
  • Kampala, Uganda
  • Tororo, Uganda