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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
Sponsor:
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Miltefosine
allometric dosing
 Drug: Miltefosine


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

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

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Kenya
Kacheliba Hospital
Kacheliba, Rift Valley, West Pokot, Kenya, 30601
Uganda
Amudat Hospital
Amudat, Karamoja, Uganda
Sponsors and Collaborators
Drugs for Neglected Diseases
Investigators
Principal Investigator: Dr. Rashid Juma, MD Kenya Medical Research Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT02431143     History of Changes
Other Study ID Numbers: LEAP 0714
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
 Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents