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The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2 investigated efficacy and safety with the selected formulation and dosage in S. mansoni infected children aged between 3 months - 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg | Experimental | 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 | Experimental | 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 | Experimental | 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. |
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| Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | Experimental | Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. |
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| Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biltricide (racemate praziquantel) oral tablets | Drug | Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Cure Determined by Kato-Katz Method | 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. | 14-21 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg Reduction Rate (Percent) | 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. | Baseline, 14-21 days post treatment |
| Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test |
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Inclusion Criteria:
Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)
S. mansoni positive diagnosis defined as positive egg counts in stool (greater than [>]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (greater than or equal to [>=]400 eggs per gram of faeces) infections
Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month infants
• Parents/legal representative ability to communicate well with the Investigator, to understand the protocol requirements and restrictions, and willing their children to comply with the requirements of the entire trial, i.e.
To be examined by a study physician at screening and 14-21 days after treatment
To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment
To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact the Communication Center | Darmstadt | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2018 | Oct 30, 2019 |
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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.
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| Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | Experimental | 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. |
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| Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | Experimental | 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. |
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| Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | Experimental | Participants aged 13-24 months months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. |
|
| Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | Experimental | 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. |
|
| Racemate Praziquantel ODT | Drug | Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4. |
|
| Levo Praziquantel ODT | Drug | Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9. |
|
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. |
| Day 2, Day 8 and 14-21 days post treatment |
Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
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| NOT COMPLETED |
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Safety analysis set included all participants who were exposed to investigative medicinal product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Cure Determined by Kato-Katz Method | 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. | 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. | Posted | Count of Participants | Participants | 14-21 days post treatment |
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| Secondary | Egg Reduction Rate (Percent) | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent reduction in egg count | Baseline, 14-21 days post treatment |
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| Secondary | Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test | 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. | 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. | Posted | Count of Participants | Participants | Day 2, Day 8 and 14-21 days post treatment |
|
Day 1 to Day 21
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 60 | 1 | 60 | 25 | 60 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 30 | 60 |
| EG002 | 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. | 0 | 60 | 1 | 60 | 29 | 60 |
| EG003 | 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. | 0 | 60 | 0 | 60 | 31 | 60 |
| EG004 | 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. | 0 | 60 | 0 | 60 | 28 | 60 |
| EG005 | 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. | 0 | 60 | 0 | 60 | 33 | 60 |
| EG006 | 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. | 0 | 60 | 0 | 60 | 37 | 60 |
| EG007 | 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. | 0 | 20 | 0 | 20 | 10 | 20 |
| EG008 | 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. | 0 | 4 | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminases increased | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
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| Malaria | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 28, 2018 | Oct 30, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
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