A Phase 3 interventional study of L-PZQ ODT 50 mg/kg and Biltricide® in Schistosomiasis, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 2 sites in 2 countries. Open to participants aged 3 Months to 6 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 3, Interventional, and Treatment
The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 288 is close to the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parent's or guardian/legally authorized representative's ability to communicate well with the Investigator and his/her delegate, to understand the protocol requirements and restrictions, and to be willing to have their children comply with the requirements of the entire study, that is:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.
Drug: L-PZQ ODT 50 mg/kg
Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.
Drug: Biltricide®
Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
Drug: L-PZQ ODT 50 mg/kg
Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
Drug: L-PZQ ODT 50 mg/kg
Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
Drug: L-PZQ ODT 50 mg/kg
Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Drug: L-PZQ ODT 60 mg/kg
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.
Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
Time frame: at Week 3
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
Time frame: at Week 3
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique
Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.
Time frame: Week 3 and Week 5
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the Kato-Katz method.
Time frame: Pre-treatment, Week 3 post-treatment
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the urine filtration technique.
Time frame: Pre-treatment, Weeks 3 and 5 post-treatment
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.
Time frame: at Week 3
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
Time frame: up to Day 40
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
Time frame: up to Day 40
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Chemistry Parameter: C Reactive Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Chemistry Parameter: Total Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
Time frame: Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.
Time frame: Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Urobilinogen
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
Time frame: Baseline, Day 1
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
Time frame: Baseline, Week 3
Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.
Time frame: Baseline, Week 3
Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.
Time frame: Baseline, Week 3
Change From Baseline in Vital Signs: Temperature
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.
Time frame: Baseline, Week 3
Number of Participants With Reaction to Study Intervention Administration
Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.
Time frame: Day 1
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score
Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter \[mm\] visual analog scale \[VAS\]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".
Time frame: Day 1
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Cmax was obtained directly from the plasma concentration versus time curve.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Tmax was obtained directly from the plasma concentration versus time curve.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
| Milestone | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Started | 100 | 50 | 30 | 18 | 30 | 60 |
| Completed | 100 | 49 | 30 | 18 | 30 | 60 |
| Not completed | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Participant travelled outside study area | 0 | 1 | 0 | 0 | 0 | 0 |
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
| Participants | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg |
|---|---|---|
| Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method | 86 | 39 |
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
| Participants | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg |
|---|---|---|
| Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method | 27 | 17 |
Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.
| Participants | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|
| Week 3 | 17 | 50 |
| Week 5 | — | 55 |
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the Kato-Katz method.
| percent reduction in egg count | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg |
|---|---|---|---|---|
| Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | 99.5 (98.8 to 99.9) | 99.2 (97.6 to 99.8) | 88.5 (56.4 to 100.0) | 95.6 (77.0 to 100.0) |
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the urine filtration technique.
| percent reduction in egg count | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|
| Week 3 | 99.4 (98.8 to 99.8) | 99.2 (98.2 to 99.8) |
| Week 5 | — | 99.3 (97.6 to 100.0) |
Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.
| Participants | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg |
|---|---|---|---|---|
| Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test | 63 | 26 | 18 | 13 |
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
| Participants | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Participants with TEAEs | 66 | 31 | 20 | 14 | 9 | 28 |
| Participants with serious TEAEs | 0 | 0 | 0 | 0 | 0 | 1 |
| Participants with treatment-related TEAEs | 31 | 14 | 16 | 4 | 0 | 5 |
Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
| Participants | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Mild | 57 | 27 | 19 | 14 | 5 | 21 |
| Moderate | 21 | 8 | 9 | 2 | 4 | 12 |
| Severe | 1 | 1 | 1 | 0 | 0 | 1 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
| picogram | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.12 ± 1.273 | 0.20 ± 0.665 | 0.18 ± 0.348 | 0.34 ± 0.699 | 0.02 ± 0.325 | 0.30 ± 1.046 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
| gram per liter (g/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Erythrocytes Mean Corpuscular HGB Concentration | -0.6 ± 10.95 | 3.1 ± 9.97 | 5.2 ± 13.85 | 3.9 ± 11.25 | 4.5 ± 6.52 | 1.0 ± 11.82 |
| Hemoglobin | -0.8 ± 8.26 | -0.0 ± 11.56 | -4.4 ± 10.29 | 1.1 ± 7.22 | -0.1 ± 6.89 | 0.8 ± 7.43 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
| femtoliters | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.24 ± 2.657 | -0.04 ± 1.247 | -0.06 ± 0.905 | 0.16 ± 2.101 | -0.88 ± 0.948 | 0.61 ± 1.381 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
| 10^12 cells per liter | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Hematology Parameter: Erythrocytes | -0.003 ± 0.3245 | -0.061 ± 0.3792 | -0.240 ± 0.5650 | -0.044 ± 0.3724 | 0.001 ± 0.2921 | -0.028 ± 0.4000 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
| percentage of cells | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Hematocrit | 0.075 ± 3.3856 | -0.434 ± 3.0010 | -1.787 ± 3.9566 | -0.144 ± 2.6203 | -0.400 ± 2.3799 | 0.103 ± 3.0415 |
| Lymphocytes/Leukocytes | 4.35 ± 10.617 | 1.69 ± 9.171 | 0.44 ± 10.390 | 6.13 ± 7.579 | 3.75 ± 7.973 | 5.82 ± 8.456 |
| Mixed Cells/Leukocytes | -1.35 ± 6.526 | 0.45 ± 7.579 | 0.07 ± 4.816 | 0.19 ± 4.597 | 1.87 ± 4.278 | -1.19 ± 6.436 |
| Neutrophils/Leukocytes | -2.01 ± 13.738 | -3.03 ± 13.733 | 0.15 ± 13.430 | -6.32 ± 8.848 | -11.68 ± 8.228 | -4.60 ± 11.336 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
| 10^9 cells per liter | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Leukocytes | -0.357 ± 2.2500 | -0.512 ± 2.3055 | -0.967 ± 1.9043 | 0.317 ± 2.1385 | -0.390 ± 1.9805 | 0.340 ± 1.9324 |
| Platelets | -21.2 ± 56.04 | -24.5 ± 39.08 | -28.6 ± 61.75 | 49.7 ± 170.67 | -10.0 ± 33.12 | -14.0 ± 62.78 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
| units per liter (U/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Alanine Aminotransferase | -1.91 ± 5.447 | -1.23 ± 6.245 | -2.03 ± 3.945 | -0.40 ± 5.959 | -1.27 ± 2.532 | -1.57 ± 3.614 |
| Aspartate Aminotransferase | -2.50 ± 9.271 | -0.59 ± 12.759 | -2.55 ± 8.910 | 4.41 ± 27.941 | -2.87 ± 4.805 | -1.93 ± 4.430 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
| micromole per liter (mcmol/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Bilirubin | -1.48 ± 3.056 | -0.22 ± 2.531 | 0.25 ± 3.651 | -1.62 ± 3.075 | — | — |
| Creatinine | 4.565 ± 10.7273 | 6.386 ± 13.9391 | 3.340 ± 16.7903 | 1.644 ± 8.2799 | 9.733 ± 10.7220 | 6.967 ± 13.1561 |
| Direct Bilirubin | 0.09 ± 0.937 | 0.06 ± 0.278 | 0.05 ± 0.219 | -0.04 ± 0.144 | -0.05 ± 0.523 | 0.07 ± 0.453 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.
| milligram per liter (mg/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Chemistry Parameter: C Reactive Protein | 0.411 ± 9.6546 | 0.004 ± 3.5448 | -0.336 ± 3.8792 | 0.872 ± 4.6025 | -0.588 ± 4.2572 | 0.283 ± 3.3653 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
| millimole per liter (mmol/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Glucose | -0.056 ± 1.2426 | 0.277 ± 1.3265 | 0.207 ± 1.2011 | -0.354 ± 1.4042 | -0.070 ± 1.0867 | -0.052 ± 1.4386 |
| Urea | 0.061 ± 0.1159 | 0.087 ± 0.0691 | 0.082 ± 0.0611 | 0.043 ± 0.0528 | — | — |
| Urea Nitrogen | 1.443 ± 1.2279 | 1.257 ± 1.1638 | 2.017 ± 1.7597 | 0.614 ± 0.9841 | 1.966 ± 1.2305 | 2.432 ± 1.3376 |
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
| gram per liter (g/L) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Chemistry Parameter: Total Protein | -5.20 ± 5.001 | -6.32 ± 5.018 | -6.22 ± 7.241 | 0.16 ± 4.918 | -3.40 ± 5.308 | -3.18 ± 4.959 |
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
| ratio | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine | 0.0066 ± 0.00797 | 0.0064 ± 0.00722 | 0.0060 ± 0.00781 | 0.0039 ± 0.00932 | 0.0047 ± 0.00787 | 0.0091 ± 0.00704 |
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.
| pH | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine | -0.33 ± 1.176 | -0.54 ± 1.068 | -0.50 ± 1.017 | -0.11 ± 0.654 | -0.42 ± 0.872 | -0.43 ± 0.899 |
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
| mcmol/L | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Urinalyses Parameter: Urobilinogen | 0.01 ± 4.069 | 0.19 ± 4.387 | 0.48 ± 2.355 | 0.00 ± 0.000 | -0.03 ± 0.146 | 0.01 ± 0.090 |
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
| millimeters of mercury (mmHg) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Diastolic Blood Pressure | 2.7 ± 10.92 | 2.0 ± 9.49 | 2.9 ± 10.58 | -1.3 ± 10.27 | 1.2 ± 12.49 | 4.1 ± 11.73 |
| Systolic Blood Pressure | -0.5 ± 12.37 | -1.4 ± 12.17 | 0.3 ± 12.58 | 0.8 ± 8.06 | -1.8 ± 9.78 | 3.7 ± 12.07 |
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.
| beats per minute | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Vital Signs: Pulse Rate | -1.8 ± 14.65 | -2.6 ± 11.90 | -4.1 ± 20.46 | -9.6 ± 20.74 | -3.7 ± 18.78 | -1.7 ± 11.90 |
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.
| breaths per minute | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Vital Sign: Respiratory Rate | 0.5 ± 4.09 | -0.1 ± 3.63 | -1.0 ± 2.98 | -3.4 ± 8.91 | -2.6 ± 3.85 | -0.9 ± 4.02 |
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.
| degree Celsius | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Change From Baseline in Vital Signs: Temperature | -0.02 ± 0.482 | -0.04 ± 0.529 | 0.21 ± 0.734 | -0.10 ± 0.484 | -0.01 ± 0.529 | 0.08 ± 0.427 |
Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.
| Participants | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Crying | 1 | 4 | 8 | 8 | 2 | 2 |
| Spitting | 1 | 3 | 6 | 6 | 0 | 3 |
| Diarrhoea | 16 | 3 | 4 | 2 | 0 | 2 |
| Sleepiness | 7 | 3 | 7 | 2 | 0 | 1 |
| Abdominal pain | 21 | 9 | 9 | 0 | 0 | 2 |
| Fever | 1 | 1 | 0 | 0 | 0 | 0 |
| Vomiting | 7 | 4 | 4 | 1 | 0 | 0 |
| Other | 3 | 1 | 0 | 0 | 0 | 1 |
Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter \[mm\] visual analog scale \[VAS\]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".
| score on a scale | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|
| Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score | 84.0 (54.0 to 91.0) | 50.0 (26.0 to 87.0) | 88.0 (69.0 to 91.0) | 88.0 (79.0 to 92.0) |
Cmax was obtained directly from the plasma concentration versus time curve.
| nanogram per milliliter (ng/mL) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| R-PZO | 347 ± 281.4 | 59.3 ± 60.39 | 1470 ± 1326 | NA ± NA | 523 ± 667.7 | 300 ± 239.7 |
| S-PZO | 1.27 ± 2.834 | 343 ± 298.9 | 0.00 ± 0.000 | NA ± NA | 0.00 ± 0.000 | 0.360 ± 1.394 |
Tmax was obtained directly from the plasma concentration versus time curve.
| hours | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| R-PZO | 02.00 (0.500 to 8.00) | 01.00 (0.00 to 12.0) | 03.00 (01.00 to 12.0) | NA (NA to NA) | 1.50 (0.500 to 6.02) | 03.00 (0.500 to 8.02) |
| S-PZO | 0.00 (0.00 to 4.00) | 2.49 (0.500 to 12.0) | 0.00 (0.00 to 8.00) | NA (NA to NA) | 0.00 (0.00 to 5.00) | 0.00 (0.00 to 5.00) |
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
| hours*nanogram per milliliter (h*ng/mL) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| R-PZO | 1080 ± 1036 | 184 ± 150.0 | 2720 ± 1718 | NA ± NA | 1190 ± 1110 | 907 ± 776.3 |
| S-PZO | 2.84 ± 0.9072 | 1240 ± 1124 | — | — | — | — |
Collected over up to Day 40. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 0/100 (0%) | 0/100 (0%) | 66/100 (66%) |
| Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 0/50 (0%) | 0/50 (0%) | 31/50 (62%) |
| Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 0/30 (0%) | 0/30 (0%) | 20/30 (66.7%) |
| Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 0/18 (0%) | 0/18 (0%) | 14/18 (77.8%) |
| Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | 0/30 (0%) | 0/30 (0%) | 9/30 (30%) |
| Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | 0/60 (0%) | 1/60 (1.7%) | 28/60 (46.7%) |
| Event | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 0/100 | 0/50 | 0/30 | 0/18 | 0/30 | 1/60 |
| Event | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg |
|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 23/100 | 10/50 | 9/30 | 0/18 | 0/30 | 2/60 |
| SomnolenceNervous system disorders | 8/100 | 3/50 | 8/30 | 2/18 | 0/30 | 1/60 |
| DiarrhoeaGastrointestinal disorders | 18/100 | 3/50 | 4/30 | 2/18 | 0/30 | 2/60 |
| GastroenteritisInfections and infestations | 3/100 | 1/50 | 1/30 | 3/18 | 0/30 | 3/60 |
| Upper respiratory tract infectionInfections and infestations | 4/100 | 1/50 | 3/30 | 1/18 | 5/30 | 3/60 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 1/100 | 1/50 | 0/30 | 3/18 | 1/30 | 4/60 |
| Urinary tract infectionInfections and infestations | 2/100 | 2/50 | 0/30 | 3/18 | 0/30 | 1/60 |
| VomitingGastrointestinal disorders | 8/100 | 5/50 | 4/30 | 1/18 | 1/30 | 0/60 |
| Tinea capitisInfections and infestations | 3/100 | 3/50 | 2/30 | 1/18 | 3/30 | 1/60 |
| NeutropeniaBlood and lymphatic system disorders | 0/100 | 0/50 | 1/30 | 0/18 | 0/30 | 5/60 |
Safety analysis population (SAF) included all participants who received 1 dose of study treatment.
| Age, Continuous(years) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 5.4 ± 0.69 | 5.5 ± 0.83 | 3.0 ± 0.59 | 1.4 ± 0.43 | 4.6 ± 1.49 | 5.1 ± 1.51 | 4.8 ± 1.54 |
| Sex: Female, Male(Participants) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Female | 52 | 21 | 16 | 11 | 9 | 28 | 137 |
| Male | 48 | 29 | 14 | 7 | 21 | 32 | 151 |
| Race (NIH/OMB)(Participants) | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 100 | 50 | 30 | 18 | 30 | 60 | 288 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Data sharing details ↗ · bit.ly
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Merck KGaA, Darmstadt, Germany →