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

NCT05957978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Primary Visceral Leishmaniasis

Interventions

DRUG

LXE408

Film-coated tablets

DRUG

sodium stibogluconate

Dosage/Administration: sodium stibogluconate 20 mg/kg/day intravenous/intramuscular (IV/IM) q.d.

DRUG

Paromomycin

Dosage/Administration: paromomycin 15 mg/kg/day IM q.d.

Sponsors & Collaborators

Principal Investigators

  • Mezgebu Silamsaw, Dr · University of Gondar, Ethiopia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-06-27
Completion
2025-11-13

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Companies

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 NCT05957978 on ClinicalTrials.gov