Trial Outcomes & Findings for An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni) (NCT NCT02806232)
NCT ID: NCT02806232
Last Updated: 2019-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
444 participants
Primary outcome timeframe
14-21 days post treatment
Results posted on
2019-11-20
Participant Flow
Participant milestones
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
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 3: Racemate Praziquantel 40 mg/kg
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
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
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 6: Levo Praziquantel 45 mg/kg
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 7: Levo Praziquantel 60 mg/kg
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 8: Levo Praziquantel 50 mg/kg
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
60
|
60
|
60
|
60
|
20
|
4
|
|
Overall Study
COMPLETED
|
59
|
56
|
59
|
60
|
58
|
58
|
60
|
20
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
0
|
2
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
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 3: Racemate Praziquantel 40 mg/kg
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
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
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 6: Levo Praziquantel 45 mg/kg
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 7: Levo Praziquantel 60 mg/kg
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 8: Levo Praziquantel 50 mg/kg
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
Baseline characteristics by cohort
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=60 Participants
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=60 Participants
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 3: Racemate Praziquantel 40 mg/kg
n=60 Participants
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
n=60 Participants
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=60 Participants
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 6: Levo Praziquantel 45 mg/kg
n=60 Participants
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 7: Levo Praziquantel 60 mg/kg
n=60 Participants
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 8: Levo Praziquantel 50 mg/kg
n=20 Participants
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 Participants
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.
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
4.1 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
4.3 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
4.4 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.2 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
4.2 years
STANDARD_DEVIATION 1.2 • n=21 Participants
|
4.3 years
STANDARD_DEVIATION 1.1 • n=10 Participants
|
4.4 years
STANDARD_DEVIATION 1.3 • n=115 Participants
|
1.7 years
STANDARD_DEVIATION 0.3 • n=6 Participants
|
0.6 years
STANDARD_DEVIATION 0.2 • n=6 Participants
|
4.1 years
STANDARD_DEVIATION 1.3 • n=64 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
205 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
239 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
444 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 14-21 days post treatmentPopulation: Modified intention-to-treat (mITT) analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study 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.
Outcome measures
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=57 Participants
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=58 Participants
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 3: Racemate Praziquantel 40 mg/kg
n=58 Participants
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
n=58 Participants
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=56 Participants
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 6: Levo Praziquantel 45 mg/kg
n=57 Participants
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 7: Levo Praziquantel 60 mg/kg
n=58 Participants
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 8: Levo Praziquantel 50 mg/kg
n=15 Participants
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Cure Determined by Kato-Katz Method
|
51 Participants
|
43 Participants
|
47 Participants
|
46 Participants
|
44 Participants
|
49 Participants
|
52 Participants
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 14-21 days post treatmentPopulation: mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study 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.
Outcome measures
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=57 Participants
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=58 Participants
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 3: Racemate Praziquantel 40 mg/kg
n=58 Participants
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
n=58 Participants
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=56 Participants
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 6: Levo Praziquantel 45 mg/kg
n=57 Participants
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 7: Levo Praziquantel 60 mg/kg
n=58 Participants
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 8: Levo Praziquantel 50 mg/kg
n=15 Participants
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Egg Reduction Rate (Percent)
|
94.6 percent reduction in egg count
Interval 89.8 to 99.4
|
83.3 percent reduction in egg count
Interval 74.7 to 91.9
|
88.6 percent reduction in egg count
Interval 81.8 to 95.4
|
88.6 percent reduction in egg count
Interval 82.2 to 94.9
|
88.3 percent reduction in egg count
Interval 81.3 to 95.3
|
92.3 percent reduction in egg count
Interval 86.4 to 98.1
|
94.1 percent reduction in egg count
Interval 88.6 to 99.6
|
97.7 percent reduction in egg count
Interval 92.9 to 100.0
|
100.0 percent reduction in egg count
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 2, Day 8 and 14-21 days post treatmentPopulation: mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study 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.
Outcome measures
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=57 Participants
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=58 Participants
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 3: Racemate Praziquantel 40 mg/kg
n=58 Participants
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
n=58 Participants
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=56 Participants
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 6: Levo Praziquantel 45 mg/kg
n=57 Participants
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 7: Levo Praziquantel 60 mg/kg
n=58 Participants
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 8: Levo Praziquantel 50 mg/kg
n=15 Participants
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
14-21 days post treatment
|
33 Participants
|
21 Participants
|
24 Participants
|
32 Participants
|
24 Participants
|
35 Participants
|
42 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Day 2
|
8 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
11 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Day 8
|
28 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
16 Participants
|
28 Participants
|
38 Participants
|
8 Participants
|
0 Participants
|
Adverse Events
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Part 1, Cohort 6: Levo Praziquantel 45 mg/kg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Part 1, Cohort 7: Levo Praziquantel 60 mg/kg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Part 2, Cohort 8: Levo Praziquantel 50 mg/kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2, Cohort 9: Levo Praziquantel 50 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=60 participants at risk
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=60 participants at risk
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 3: Racemate Praziquantel 40 mg/kg
n=60 participants at risk
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
n=60 participants at risk
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=60 participants at risk
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 6: Levo Praziquantel 45 mg/kg
n=60 participants at risk
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 7: Levo Praziquantel 60 mg/kg
n=60 participants at risk
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 8: Levo Praziquantel 50 mg/kg
n=20 participants at risk
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Transaminases increased
|
1.7%
1/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
1.7%
1/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
0.00%
0/20 • Day 1 to Day 21
|
0.00%
0/4 • Day 1 to Day 21
|
Other adverse events
| Measure |
Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg
n=60 participants at risk
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 2: Biltricide (Racemate Praziquantel) 40 mg/kg
n=60 participants at risk
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 3: Racemate Praziquantel 40 mg/kg
n=60 participants at risk
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
n=60 participants at risk
Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
|
Part 1, Cohort 5: Levo Praziquantel 30 mg/kg
n=60 participants at risk
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 6: Levo Praziquantel 45 mg/kg
n=60 participants at risk
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 7: Levo Praziquantel 60 mg/kg
n=60 participants at risk
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 8: Levo Praziquantel 50 mg/kg
n=20 participants at risk
Participants aged 13-24 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 9: Levo Praziquantel 50 mg/kg
n=4 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
15/60 • Day 1 to Day 21
|
41.7%
25/60 • Day 1 to Day 21
|
38.3%
23/60 • Day 1 to Day 21
|
36.7%
22/60 • Day 1 to Day 21
|
30.0%
18/60 • Day 1 to Day 21
|
36.7%
22/60 • Day 1 to Day 21
|
48.3%
29/60 • Day 1 to Day 21
|
25.0%
5/20 • Day 1 to Day 21
|
100.0%
4/4 • Day 1 to Day 21
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
5/60 • Day 1 to Day 21
|
5.0%
3/60 • Day 1 to Day 21
|
5.0%
3/60 • Day 1 to Day 21
|
8.3%
5/60 • Day 1 to Day 21
|
6.7%
4/60 • Day 1 to Day 21
|
0.00%
0/60 • Day 1 to Day 21
|
10.0%
6/60 • Day 1 to Day 21
|
5.0%
1/20 • Day 1 to Day 21
|
0.00%
0/4 • Day 1 to Day 21
|
|
Infections and infestations
Bronchitis
|
15.0%
9/60 • Day 1 to Day 21
|
11.7%
7/60 • Day 1 to Day 21
|
5.0%
3/60 • Day 1 to Day 21
|
8.3%
5/60 • Day 1 to Day 21
|
6.7%
4/60 • Day 1 to Day 21
|
5.0%
3/60 • Day 1 to Day 21
|
13.3%
8/60 • Day 1 to Day 21
|
10.0%
2/20 • Day 1 to Day 21
|
0.00%
0/4 • Day 1 to Day 21
|
|
Infections and infestations
Malaria
|
8.3%
5/60 • Day 1 to Day 21
|
5.0%
3/60 • Day 1 to Day 21
|
8.3%
5/60 • Day 1 to Day 21
|
1.7%
1/60 • Day 1 to Day 21
|
6.7%
4/60 • Day 1 to Day 21
|
6.7%
4/60 • Day 1 to Day 21
|
3.3%
2/60 • Day 1 to Day 21
|
25.0%
5/20 • Day 1 to Day 21
|
25.0%
1/4 • Day 1 to Day 21
|
|
Investigations
C-reactive protein increased
|
11.7%
7/60 • Day 1 to Day 21
|
6.7%
4/60 • Day 1 to Day 21
|
16.7%
10/60 • Day 1 to Day 21
|
13.3%
8/60 • Day 1 to Day 21
|
11.7%
7/60 • Day 1 to Day 21
|
23.3%
14/60 • Day 1 to Day 21
|
10.0%
6/60 • Day 1 to Day 21
|
0.00%
0/20 • Day 1 to Day 21
|
0.00%
0/4 • Day 1 to Day 21
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place