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Artefenomel and Ferroquine in Uncomplicated Malaria
NCT03660839Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2018
- Primary completion
- Nov 2019
- Countries
- 5
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- artefenomel
- Conditions
- Plasmodium falciparum malaria
01
Overview
Phase 2, randomised, open-label trial of artefenomel in Plasmodium falciparum malaria (4 arms), sponsored by Sanofi. Primary endpoint: PCR-Corrected Adequate Clinical and Parasitological Response at Day 28. Started Sep 2018; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Ferroquine 400 mg
Single dose Ferroquine 400 mg
FQ 400 mg + OZ 300 mg
Single dose Ferroquine 400 mg + Artefenomel 300 mg
FQ 400 mg + OZ 600 mg
Single dose Ferroquine 400 mg + Artefenomel 600 mg
FQ 400 mg + OZ 1000 mg
Single dose Ferroquine 400 mg + Artefenomel 1000 mg
03
Who it enrols
Patients 14-69 years old with uncomplicated P. falciparum malaria, fever, and parasitemia 3,000-50,000/uL. Excludes severe malaria, significant organ dysfunction, QTcF > 450ms, and recent antimalarial use.
04
Endpoints
Primary
PCR-Corrected Adequate Clinical and Parasitological Response at Day 28
Secondary
Crude Adequate Clinical and Parasitological Response at Day 28
Change From Baseline in Number of Parasites
Parasite Reduction Ratio
Parasite Clearance Time
Concentration of OZ439 in Plasma
Treatment-Emergent Adverse Events
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