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

A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory 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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neopharma Japan Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 75 patients will be randomized in a 1:2:2 ratio to 3 arms: Arm 1: placebo+ACT group (15 patients) Arm 2: 5 ALA/SFC+Placebo+ACT twice daily (BID) (30 patients) Arm 3: 5-ALA/SFC+Placebo+ACT once daily (QD) (30 patients) The study duration will be a maximum of 98 days with treatment period of 7 days and follow-up period of 91 days.

Conditions

• Malaria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-06
• Primary completion: 2020-05-31
• Completion: 2020-09-30
• First posted: 2019-07-16
• Last updated: 2020-03-03