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

NCT04020653 · clinicaltrials.gov ↗

PHASE2

Phase

WITHDRAWN

Status

INDUSTRY

Sponsor class

Stopped Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.

Conditions

Malaria

Interventions

DRUG: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD
DRUG: Sodium ferrous citrate (SFC) 472 mg QD
DRUG: Artemisinin-based combination (ACT)
DRUG: Placebo
DRUG: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID
DRUG: Sodium ferrous citrate (SFC) 236 mg BID

Sponsor

Neopharma Japan Co., Ltd.

Collaborators

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