NCT04020653 - 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 | Biotech Hunter

Timeline

Start Date

September 6, 2019

Primary Completion Date

May 31, 2020

Study Completion Date

September 30, 2020

Conditions

Malaria

Interventions

DRUG

5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD

5-ALA HCl 150 mg capsules will be given to the patients as 600 mg QD

DRUG

Sodium ferrous citrate (SFC) 472 mg QD

SFC 118 mg capsules will be given to the patients as 472 mg QD

DRUG

Artemisinin-based combination (ACT)

Tablets of ACT will be administered following Dosage and Administration in the package insert of ACT. ACT will be supplied as a combination tablet.

DRUG

Placebo

Matching placebo capsules to 5-ALA HCl and SFC will be administered to the patients

DRUG

5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID

5-ALA HCl 150 mg capsules will be given to the patients as 300 mg BID

DRUG

Sodium ferrous citrate (SFC) 236 mg BID

SFC 118 mg capsules will be given to the patients as 236 mg BID