A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria

• Status: Withdrawn
• Trial end date: 2020-09-30

Summary

This is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Patients who are suffering from uncomplicated malaria, are eligible for randomization.The study will be conducted in a total of 75 patients with uncomplicated malaria.

• Phase: Phase 2

Details

• Lead Sponsor: Neopharma Japan Co., Ltd.
• Collaborator: Parexel
• Treatments: Aminolevulinic Acid; Artemether; Artemisinin; Artemisinine; Artemisinins; Citric Acid; Ferrous citrate; Lumefantrine; Monoferrous acid citrate; Sodium Citrate