Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
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|ClinicalTrials.gov Identifier: NCT02431143|
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Visceral Leishmaniasis||Drug: Miltefosine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||September 2016|
- Pharmacokinetics Parameters (Area Under the Curve (AUC) - composite outcome) [ Time Frame: During treatment, at 1 and 6 months follow-up ]Area Under the Curve calculation is based on several timepoints from first drug intake up to complete elimination of the drug.
- Safety (composite outcome) adverse events [ Time Frame: until day 210 ]1. Frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs) requiring treatment discontinuation, 2. Frequency and severity of adverse events
- Pharmacokinetics Parameters (Css/Cmax) [ Time Frame: Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431143
|Kacheliba, Rift Valley, West Pokot, Kenya, 30601|
|Amudat, Karamoja, Uganda|
|Principal Investigator:||Dr. Rashid Juma, MD||Kenya Medical Research Institute|