Brief Title
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
Official Title
Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Raziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziquantel) in Schistosomiasis (S. Mansoni) Infected Children Aged 2-6 Years (Part 1), Followed by an Assessment of Efficacy and Safety With the Selected Formulation and Dosage in S. Mansoni Infected Infants Aged 3-24 Months (Part 2)
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Clinical Cure Determined by Kato-Katz Method
Secondary Outcome
Egg Reduction Rate (Percent)
Condition
Schistosomiasis
Intervention
Biltricide (racemate praziquantel) oral tablets
Study Arms / Comparison Groups
Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg
Description: Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
444
Start Date
June 12, 2016
Completion Date
November 17, 2018
Primary Completion Date
October 30, 2018
Eligibility Criteria
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: - Treatment in the 4 weeks prior to study screening with Praziquantel (PZQ) , other anti-helminthic, antimalarial or anti-retroviral compounds or any other medication that might affect the PK of PZQ such as certain antiepileptics (e.g., carbamazepine or phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or cimetidine - For children being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to administration of Investigational medicinal product - Previous history of adverse reactions associated with PZQ treatment - Marked increases of the liver transaminases (alanine aminotransferase and/or aspartate aminotransferase) above 3x Upper Limit of Normal (ULN) - History of acute or severe chronic disease including hepato-splenic schistosomiasis - Fever defined as temperature above 38.0 degree centigrade - Debilitating illnesses such as tuberculosis, malnutrition, etc. as well as a medical history of seizures - Mixed S. haematobium and S. mansoni infections - Findings in the clinical examination of schistosome-infected children participating in the study as performed by the study clinician on the treatment day, that in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation - Unlikelihood to comply with the protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
Gender
All
Ages
3 Months - 6 Years
Accepts Healthy Volunteers
No
Contacts
Medical Responsible, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02806232
Organization ID
200661-0005
Responsible Party
Sponsor
Study Sponsor
Merck KGaA, Darmstadt, Germany
Study Sponsor
Medical Responsible, Study Director, Merck KGaA, Darmstadt, Germany
Verification Date
October 2019