Status and phase
Conditions
Treatments
About
The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2 investigated efficacy and safety with the selected formulation and dosage in S. mansoni infected children aged between 3 months - 2 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)
S. mansoni positive diagnosis defined as positive egg counts in stool (greater than [>]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (greater than or equal to [>=]400 eggs per gram of faeces) infections
Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month infants
• Parents/legal representative ability to communicate well with the Investigator, to understand the protocol requirements and restrictions, and willing their children to comply with the requirements of the entire trial, i.e.
To be examined by a study physician at screening and 14-21 days after treatment
To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment
To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
444 participants in 9 patient groups
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Data sourced from clinicaltrials.gov
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