Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331136
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2006-05-26
Brief Title:
Pyronaridine and Artesunate 31 in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Sponsor:
Medicines for Malaria Venture
Organization:
Medicines for Malaria Venture
Study Overview
Official Title:
An Open-label Phase II Dose-Escalation Clinical Study to Assess the Pharmacokinetics Safety Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate 31 in Children With Acute Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate PA for the treatment of acute uncomplicated falciparum malaria in children
Detailed Description:
This is a Phase II open-label sequential-group dose-escalation single-centre study to study pharmacokinetics bioavailability comparison of tablets vs granules and safetytolerability of PA in paediatric patients with acute symptomatic uncomplicated P falciparum malaria The study population will include 60 patients comprising male and female children recruited from a single study site located in the endemic region of Gabon
Patients will be assigned sequentially to 1 of 4 treatment groups 15 per group Group A Tablets PA 48 mg 16 mg Group B Tablets PA 72 mg 24 mg Group C Tablets PA 96 mg 32 mg Group D Granules PA 60 mg 20 mg Oral tablets will be taken once daily for 3 consecutive days Days 0 1 and 2 The dose given to each patient depends on the dosing cohort group and the patients body weight
Each patient will attend the study site for screening and baseline procedures as well as receipt of the first dose of study drug on Day 0 Visit 1 baseline Patients will be hospitalised for the first 72 hours and remain near the study site for the entire duration of the study The patients will return to the study site for all scheduled follow-up visits until discharge on Day 42
The primary efficacy end point for the study is the incidence of patients with PCR-corrected adequate clinical and parasitological response ACPR on Day 28 In the case of adverse events reported and unresolved at Day 42 patients will be followed up for a further 30 days or until resolution of the event
Patients will be assigned sequentially to 1 of 4 treatment groups 15 per group Group A Tablets PA 48 mg 16 mg Group B Tablets PA 72 mg 24 mg Group C Tablets PA 96 mg 32 mg Group D Granules PA 60 mg 20 mg Oral tablets will be taken once daily for 3 consecutive days Days 0 1 and 2 The dose given to each patient depends on the dosing cohort group and the patients body weight
Each patient will attend the study site for screening and baseline procedures as well as receipt of the first dose of study drug on Day 0 Visit 1 baseline Patients will be hospitalised for the first 72 hours and remain near the study site for the entire duration of the study The patients will return to the study site for all scheduled follow-up visits until discharge on Day 42
The primary efficacy end point for the study is the incidence of patients with PCR-corrected adequate clinical and parasitological response ACPR on Day 28 In the case of adverse events reported and unresolved at Day 42 patients will be followed up for a further 30 days or until resolution of the event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None