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Also known as Biltricide (Reference), Biltricide (racemate praziquantel) oral tablets
Biltricide · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | EXPERIMENTAL | 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 | 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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...
Biltricide is used for the treatment of schistosomiasis, a parasitic infection. It is an oral tablet medicine. The reference product is studied in children and infants infected with Schistosoma mansoni. It is being developed by Merck KGaA.
Biltricide is developed by Merck KGaA, which trades under the ticker MKGAF. The company is the developer of the reference oral tablet form of the medicine.
Biltricide is in Phase 2 clinical development for schistosomiasis. It is investigational and has not been approved for this use based on the available information. The Phase 2 program has one completed trial.
Biltricide has been studied in one Phase 2 trial, NCT02806232, titled an open label dose finding safety and efficacy study in children and infants infected with schistosomiasis (S. mansoni). The trial was completed, enrolled 444 participants, and was conducted in Germany.
Biltricide is also known as the racemate praziquantel oral tablets. The reference product is the racemate form of praziquantel. This alternative name is used for the same oral tablet medicine.