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A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis

NCT05593666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-04-30

No results posted yet for this study

Summary

This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.

Conditions

  • Primary Visceral Leishmaniasis

Interventions

DRUG

LXE408

Film-coated tablets

OTHER

Placebo

Placebo film-coated tablets

DRUG

AmBisome®

Sterile lyophilised powder in a 15 mL sterile clear glass vial

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-27
Primary Completion
2025-04-15
Completion
2025-12-22

Countries

  • India

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 NCT05593666 on ClinicalTrials.gov