Status:
WITHDRAWN
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
Lead Sponsor:
Neopharma Japan Co., Ltd.
Collaborating Sponsors:
Parexel
Conditions:
Malaria
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- Male or female patients of 18 to 60 years inclusive.
- Weighing 35 to 90 kg.
- Women with child bearing potential willing to give consent for pregnancy test.
- Presence of symptomatic uncomplicated malaria of all species inclusive with a diagnosis confirmed by:
- A. Microscopically confirmed parasite infection, between 500 and 100,000 asexual parasite count/μL of blood.
- B. Fever, as defined by axillary/tympanic of ≥37.5°C within 24 hours before randomization (must be documented).
- Patients must be willing and able to give written informed consent and comply with all study visits and procedures. If a patient cannot read informed consent and/or write a signature, an impartial witness who speaks the language of the patient must be present during the entire informed consent process and discussion with the patient.
Exclusion
- Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization (WHO) Criteria 2010.
- Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment.
- Known history of photo-hypersensitivity, porphyria, or hemochromatosis.
- Have taken any medication with antimalarial or antibiotic with antimalarial effect within 14 days before randomization.
- Received an investigational drug within the past 28 days.
- Patients whose Hemoglobin (Hb) level is lower than 8 g/dL.
- Liver function tests (aspartate aminotransferase/alanine aminotransferase \[AST/ALT\] levels) more than 2.5 times upper limit of normal values.
- Known human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) positive, testing is not required.
- Known significant renal impairment as indicated by serum creatinine of ≥1.4 mg/dL or estimated glomerular filtration rate (eGFR) of \<45 mL/min.
- Known history of hypersensitivity, allergic or adverse reactions to 5-aminolevulinic acid and sodium ferrous citrate.
- Presence or history of uncontrolled systemic disease.
- Female patients who are pregnant or breast-feeding.
- Any other condition in the opinion of the investigator makes the patient unsuitable for study
- Received any medication specified as contraindication for ACT or affecting blood concentration of ACT within 5 times the half-life of each medication before the first dose of study medication.
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04020653
Start Date
September 6 2019
End Date
September 30 2020
Last Update
March 3 2020
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