Trial · NCT02806232
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
NCT02806232, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2019-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni). Trials, record NCT02806232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02806232
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
- NCT number
- NCT02806232
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 444 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Schistosomiasis
- Interventions
- Biltricide (racemate praziquantel) oral tablets, Racemate Praziquantel ODT, Levo Praziquantel ODT
- First posted
- 2016-06-20
- Last updated
- 2019-11-20
- Results first posted
- 2019-11-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Cure Determined by Kato-Katz Method | 14-21 days post treatment | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Egg Reduction Rate (Percent) | Baseline, 14-21 days post treatment | 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 | GEOMETRIC_MEAN |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 51 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg | 43 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | 47 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | 46 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | 44 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | 49 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | 52 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | 14 | Participants | ||
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | 4 | Participants | ||
| Egg Reduction Rate (Percent) | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 94.6 | 95% Confidence Interval 89.8 to 99.4 | percent reduction in egg count |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | 60 | |
| Overall Study | STARTED | Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | 60 | |
| Overall Study | STARTED | Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | 20 | |
| Overall Study | STARTED | Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | 4 | |
| Overall Study | COMPLETED | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 59 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 15 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg | 25 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | 23 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | 22 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | 18 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | 22 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | 29 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | 5 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | 4 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 5 | 60 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | 0 | 60 |
| Total, all-cause mortality | Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | 0 | 20 |
| Total, all-cause mortality | Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | 0 | 4 |
| Total, other adverse events | Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg | 25 | 60 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02806232
GET https://conductscience.org/api/trials/v1/NCT02806232/results?page=2