Trial · NCT03845140
L-PZQ ODT in Schistosoma Infected Children
NCT03845140, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2024-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. L-PZQ ODT in Schistosoma Infected Children. Trials, record NCT03845140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03845140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- L-PZQ ODT in Schistosoma Infected Children
- NCT number
- NCT03845140
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 288 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Schistosomiasis
- Interventions
- L-PZQ ODT 50 mg/kg, Biltricide®, L-PZQ ODT 60 mg/kg
- First posted
- 2019-02-19
- Last updated
- 2024-03-21
- Results first posted
- 2024-03-21
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method | at Week 3 | 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. |
| Secondary | Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method | at Week 3 | 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. |
| Secondary | Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique | Week 3 and Week 5 | 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. |
| Secondary | Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | Pre-treatment, Week 3 post-treatment | 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. |
| Secondary | Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique | Pre-treatment, Weeks 3 and 5 post-treatment | 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. |
| Secondary | 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 | at Week 3 | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs | up to Day 40 | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale | up to Day 40 | 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. |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline, Day 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. |
| Secondary | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin | Baseline, Day 1 | 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method | at Week 3 | Modified intent to treat analysis population (mITT) included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Only 1 participant from Cohort 1b was lost to follow-up and was imputed as non-cured. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method | at Week 3 | mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique | Week 3 and Week 5 | mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here Number Analyzed signifies those participants who were evaluated at the specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | Pre-treatment, Week 3 post-treatment | mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. | percent reduction in egg count | NUMBER |
| SECONDARY | Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique | Pre-treatment, Weeks 3 and 5 post-treatment | mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here Number Analyzed signifies those participants who were evaluated at the specified time point. | percent reduction in egg count | NUMBER |
| SECONDARY | 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 | at Week 3 | mITT analysis population included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs | up to Day 40 | SAF anlysis population included all participants who received 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale | up to Day 40 | SAF anlysis population included all participants who received 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline, Day 1 | SAF included all participants who received 1 dose of study treatment. | picogram | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin | Baseline, Day 1 | SAF included all participants who received 1 dose of study treatment. | gram per liter (g/L) | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group308
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 86 | Participants | ||
| Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 39 | Participants | ||
| Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 27 | Participants | ||
| Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 17 | Participants | ||
| Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | Week 3 | 17 | Participants | |
| Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | Week 3 | 50 | Participants | |
| Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | Week 5 | 55 | Participants | |
| Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 99.5 | 95% Confidence Interval 98.8 to 99.9 | percent reduction in egg count | |
| Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 99.2 | 95% Confidence Interval 97.6 to 99.8 | percent reduction in egg count | |
| Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 88.5 | 95% Confidence Interval 56.4 to 100.0 | percent reduction in egg count |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 100 | |
| Overall Study | STARTED | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 50 | |
| Overall Study | STARTED | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 30 | |
| Overall Study | STARTED | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 18 | |
| Overall Study | STARTED | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | 30 | |
| Overall Study | STARTED | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | 60 | |
| Overall Study | COMPLETED | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 100 | |
| Overall Study | COMPLETED | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 49 | |
| Overall Study | COMPLETED | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 30 | |
| Overall Study | COMPLETED | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events168
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 | Abdominal pain | Gastrointestinal disorders | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 23 | 100 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 10 | 50 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 9 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 0 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | 0 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | 2 | 60 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 18 | 100 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 3 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 4 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 2 | 18 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 0 | 100 |
| Total, all-cause mortality | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 0 | 50 |
| Total, all-cause mortality | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 0 | 30 |
| Total, all-cause mortality | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 0 | 18 |
| Total, all-cause mortality | Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg | 0 | 30 |
| Total, all-cause mortality | Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg | 0 | 60 |
| Total, other adverse events | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | 66 | 100 |
| Total, other adverse events | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 31 | 50 |
| Total, other adverse events | Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg | 20 | 30 |
| Total, other adverse events | Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg | 14 | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36893784 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg vs 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 | Trial comparisons |
| Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg vs 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 | Trial comparisons |
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/NCT03845140
GET https://conductscience.org/api/trials/v1/NCT03845140/registered?page=2