Trial Profile
An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 25 Mar 2024
Price :
$35
*
At a glance
- Drugs Praziquantel (Primary)
- Indications Schistosomiasis
- Focus Registrational; Therapeutic Use
- Sponsors Merck KGaA
- 17 Dec 2023 According to Astellas Pharma media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged children (3 months to 6 years of age) on December 15. EMA assessed arpraziquantel under the EU-Medicines for all (EU-M4all) *1 procedure for high-priority medicines intended for use in countrie
- 02 Dec 2022 According to a Merck & Co media release, EMA has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (3 months to 6 years of age).
- 13 Oct 2021 Status changed from recruiting to completed.