An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
- Conditions
- Schistosomiasis
- Interventions
- Registration Number
- NCT02806232
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
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Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)
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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
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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.
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To be examined by a study physician at screening and 14-21 days after treatment
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To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment
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To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg Biltricide (racemate praziquantel) oral tablets Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. Part 1, Cohort 5: Levo Praziquantel 30 mg/kg Levo Praziquantel ODT Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1. Part 1, Cohort 7: Levo Praziquantel 60 mg/kg Levo Praziquantel ODT Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. Part 2, Cohort 9: Levo Praziquantel 50 mg/kg Levo Praziquantel ODT Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. Part 2, Cohort 8: Levo Praziquantel 50 mg/kg Levo Praziquantel ODT Participants aged 13-24 months months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. Part 1, Cohort 6: Levo Praziquantel 45 mg/kg Levo Praziquantel ODT Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1. Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg Biltricide (racemate praziquantel) oral tablets 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. Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg Racemate Praziquantel ODT Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg Racemate Praziquantel ODT Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Cure Determined by Kato-Katz Method 14-21 days post treatment Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test Day 2, Day 8 and 14-21 days post treatment Clinical Cure defined as no parasite eggs in the stools as assessed by the commercially available POC-CCA assay for S. mansoni. Number of participants with clinical cure were reported.
Egg Reduction Rate (Percent) Baseline, 14-21 days post treatment Percent reduction in egg count was calculated as geometric mean egg count at post-treatment minus geometric mean egg count at baseline (before treatment) divided by geometric mean egg count at baseline.
Trial Locations
- Locations (1)
Please Contact the Communication Center
🇩🇪Darmstadt, Germany