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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NCT04020653 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-03-03

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Neopharma Japan Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2020-05-31
Completion
2020-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020653 on ClinicalTrials.gov