Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria

PHASE2CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

August 13, 2024

Study Completion Date

August 28, 2024

Conditions
Uncomplicated Plasmodium Falciparum Malaria
Interventions
DRUG

KAF156

Provided as 50 mg or 100 mg tablets, to be taken QD 2 or 3 Days in combination with LUM-SDF, dose is based on body weight

DRUG

LUM-SDF

Provided as 60 mg, 120 mg or 240 mg powder in sachet, to be taken QD 2 or 3 Days in combination with KAF156, dose is based on body weight

DRUG

Coartem

Coartem® (dispersible tablets in blister pack) (for Cohorts 1 and 2), dose is based on body weight

Trial Locations (9)

Unknown

Novartis Investigative Site, Banfora

Novartis Investigative Site, Ouagadougou

Novartis Investigative Site, Commune de La Kenya Lubumbashi

Novartis Investigative Site, Kati

Novartis Investigative Site, Sotouba

01

Novartis Investigative Site, Bobo-Dioulasso

06 BP 10248

Novartis Investigative Site, Sabou

13BP972

Novartis Investigative Site, Abidjan

BP 242

Novartis Investigative Site, Lambaréné

Sponsors
All Listed Sponsors
collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

Novartis Pharmaceuticals

INDUSTRY