Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02431143
• Date of registration: 20/04/2015
• Prospective Registration: Yes
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02431143
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Kenya, Uganda

Contacts

• Name: Dr. Rashid Juma, MD
• Affiliation: Kenya Medical Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with clinical signs and symptoms of VL and confirmatory parasitological
microscopic diagnosis

- Patients aged > 4 to < 12 years who are able to comply with the study protocol.

- Patients for whom written informed consent has been signed by parents(s) or legal
guardian

- Weight < 30 kg

Exclusion Criteria:

- Patients who are relapse cases

- Patients who have received any anti-leishmanial drugs in the last 6 months

- Patients with severe malnutrition (for children aged <5 years, weight-for-height WHO
reference curves by gender, z score <-3; for children 5-12 years, BMI-for-age WHO
reference curves for gender, z score < -3)

- Patients with positive HIV diagnosis

- Patients with previous history of hypersensitivity reaction to miltefosine

- Patients suffering from a concomitant severe infection such as Tuberculosis (TB) or
any other serious underlying disease (cardiac, renal, hepatic) which would preclude
evaluation of the patient's response to study medication

- Patients suffering from other conditions associated with splenomegaly such as
schistosomiasis

- Pregnant or lactating women or female patient in childbearing age (reached menarche)

- Patients with haemoglobin < 5g/dl

- Patients with White Blood Cells (WBC) < 1 x 10³/mm³

- Patients with platelets < 40,000/mm³

- Patients with abnormal liver function (ALT and AST) tests of more than three times
the normal range.

- Patients with bilirubin more than 1.5 times the upper normal range

- Patients with serum creatinine above the upper limit of normal (ULN) for age and
gender.

- Patients with clinical signs of severe VL disease such as jaundice and bleeding

- Patients who cannot comply with the planned scheduled visits and procedures of the
study protocol



Age minimum: 4 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Visceral Leishmaniasis

Intervention(s)

Drug: Miltefosine

Primary Outcome(s)

Pharmacokinetics Parameters (Area Under the Curve (AUC) - composite outcome) [Time Frame: During treatment, at 1 and 6 months follow-up]

Pharmacokinetics Parameters (Css/Cmax) [Time Frame: Day 28]

Safety (composite outcome) adverse events [Time Frame: until day 210]

Secondary ID(s)

LEAP 0714

Source(s) of Monetary Support

Please refer to primary and secondary sponsors