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
Verified date | October 2016 |
Source | Drugs for Neglected Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | Kenya: Pharmacy and Poisons Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 12 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Kenya | Kacheliba Hospital | Kacheliba | Rift Valley, West Pokot |
Uganda | Amudat Hospital | Amudat | Karamoja |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases |
Kenya, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics Parameters (Area Under the Curve (AUC) - composite outcome) | Area Under the Curve calculation is based on several timepoints from first drug intake up to complete elimination of the drug. | During treatment, at 1 and 6 months follow-up | No |
Primary | Safety (composite outcome) adverse events | 1. Frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs) requiring treatment discontinuation, 2. Frequency and severity of adverse events | until day 210 | Yes |
Primary | Pharmacokinetics Parameters (Css/Cmax) | Day 28 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02839603 -
Asymptomatic Leishmania Infection in HIV Patients
|
||
Completed |
NCT00370825 -
Combination Chemotherapy for the Treatment of Indian Kala-Azar
|
Phase 2 | |
Recruiting |
NCT05426577 -
Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
|
||
Completed |
NCT01069198 -
A Community Trial for Visceral Leishmaniasis (VL)
|
N/A | |
Completed |
NCT00604955 -
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
|
Phase 4 | |
Completed |
NCT01032187 -
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
|
Phase 4 | |
Completed |
NCT00371995 -
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
|
Phase 2 | |
Completed |
NCT00342823 -
Immunogenetics of Visceral Leishmaniasis
|
N/A | |
Completed |
NCT04003532 -
LAMP Assay for the Diagnosis of Visceral Leishmaniasis
|
||
Terminated |
NCT01980199 -
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
|
Phase 2 | |
Completed |
NCT00255567 -
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
|
Phase 3 | |
Not yet recruiting |
NCT06118749 -
Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
|
||
Recruiting |
NCT04342715 -
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
|
||
Completed |
NCT01122771 -
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
|
Phase 3 | |
Completed |
NCT03636659 -
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
|
Phase 1 | |
Not yet recruiting |
NCT01566552 -
Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
|
Phase 4 | |
Completed |
NCT00696969 -
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
|
Phase 3 | |
Completed |
NCT00318721 -
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
|
N/A | |
Completed |
NCT00216346 -
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
|
Phase 3 | |
Completed |
NCT02011958 -
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
|
Phase 3 |