CompletedPhase 2

LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study

Ethiopia52 participantsStarted 2024-03-29

Plain-language summary

This is a randomized, open-label, phase II, single-centre study, with one LXE408 regimen and one calibrator arm with the standard of care SSG combined with PM, to be conducted in male and female adult (≥18 years and \<45 years) patients with confirmed primary visceral leishmaniasis in Ethiopia.

Who can participate

Age range18 Years – 44 Years

SexALL

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Exclusion criteria

✕. Clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia and clinically significant second- or third-degree AV block without a pacemaker)
✕. QTcF ≥ 450 ms
✕. History of familial long QT syndrome or known family history of Torsades de Pointes
✕. Resting heart rate (physical exam or 12 lead ECG) \<60 bpm

What they're measuring

Proportion of patients treated with LXE408 with initial cure at Day 28

Timeframe: Day 28

Trial details

NCT IDNCT05957978

SponsorDrugs for Neglected Diseases

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Primary Visceral Leishmaniasis trials