Trial intelligence / Profile preview

Safety of Primaquine with DHAP in G6PD Deficient Males

NCT02654730Phase 3

Key facts

Status: Terminated
Start: Dec 2015
Primary completion: Sep 2016
Countries: 1
Sponsor: London School of Hygiene & Tropical Medicine
Modality: Small Molecules

Drugs: primaquine
Conditions: malaria

Overview

Phase 3, open-label trial of primaquine in malaria (5 arms), sponsored by London School of Hygiene & Tropical Medicine. Primary endpoint: Haemoglobin concentration relative to baseline value at 28 days. Started Dec 2015; status: terminated.

Design

5 arms

Study design: Non-randomizedOpen-label

G6PD deficient 0.25 mg/kg PQ + DHAP
G6PD deficient participants receiving DHAP + 0.25 mg/kg Primaquine
G6PD deficient 0.4 mg/kg PQ + DHAP
G6PD deficient participants receiving DHAP + 0.4 mg/kg Primaquine
G6PD deficient DHAP only
G6PD deficient participants receiving DHAP only
G6PD normal 0.25 mg/kg PQ + DHAP
G6PD normal participants receiving DHAP + 0.25 mg/kg Primaquine
G6PD normal 0.4 mg/kg PQ + DHAP
G6PD normal participants receiving DHAP + 0.4 mg/kg Primaquine

Who it enrols

Male participants aged 10 years or older with G6PD deficiency (for intervention arms) or normal G6PD activity (for control arms), and haemoglobin levels >= 11 g/dL. Exclusion criteria include fever, severe illness, recent antimalarial use, and use of drugs known to cause haemolysis.

Endpoints

Primary

Haemoglobin concentration relative to baseline value28 days

Secondary

Haptoglobin concentration28 days
Bilirubin concentration28 days
Lactate dehydrogenase28 days
Creatinine concentration28 days
Potassium concentration28 days
Number of participants with treatment-related adverse events28 days
Mean corpuscular volume28 days
Red cell distribution width28 days

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