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
| 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 |
NCT00371995 -
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
|
Phase 2 | |
| 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 |
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 |