drugset / Trial / NCT03311607

Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh

NCT03311607

Phase 4 Completed 280 enrolled Medecins Sans Frontieres, Netherlands
NaSingle-groupOpen-labelTreatment

Summary

The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.

Timeline

Start
2014-04-08
Primary completion
2015-10-14
Completion
2015-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 3 mg/kg