# 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 **NCT04020653** · PHASE2 · WITHDRAWN · sponsor: **Neopharma Japan Co., Ltd.**

## Conditions studied

- 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

## Key facts

- **NCT ID:** NCT04020653
- **Lead sponsor:** Neopharma Japan Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2019-09-06
- **Primary completion:** 2020-05-31
- **Final completion:** 2020-09-30
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.
- **Last updated:** 2020-03-03

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04020653

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT04020653. Licensed CC0.

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