Visceral Leishmaniasis Clinical Trial
Official title:
An Open-label Clinical Trial to Assess the Pharmacokinetics and Safety of Miltefosine Allometric Dose for the Treatment of Children With Primary Visceral Leishmaniasis in Eastern Africa
This is a multicenter, non-comparative, open-label clinical trial to assess the
Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the
treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy
and Pharmacodynamics (PD) will be assessed as secondary outcomes.
The proposed study aims to assess whether drug exposure in children can be increased to
equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28
days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present
study is also expected to provide the basis for minimum time to reach sufficient drug
exposure for miltefosine activity to guide optimal treatment duration to be used in
combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial
using a compartmental population PK approach.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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