10 December 2018

Pediatric Praziquantel Consortium successfully completed Phase II in Ivory Coast

The important milestone of Last Patient Last Visit (LPLV) in the clinical Phase II trial was achieved on November 17, 2018

The Pediatric Praziquantel (PZQ) Formulation program led by Merck KGaA, Darmstadt, Germany within a Consortium of partners from private and public sectors, reached an important milestone: the Last Patient Last Visit (LPLV) in the clinical Phase II trial was recorded on November 17, 2018.

The investigators responsible for implementing the Phase II trial were provided by the Université Félix Houphouët-Boigny (UFHB), one of the eight Consortium partners, in Ivory Coast.  The study aimed at assessing the efficacy and safety of two different orodispersible tablets (ODTs) formulations of PZQ in schistosoma-infected children under the age of six. Current results indicate that both ODT formulations are well tolerated at all doses tested; one formulation, levopraziquantel (L-PZQ) ODT, is confirmed for further development.

Village of Kpanzaopleu (Department of Man, Ivory Coast):  Last child enrolled in the Phase II study

Implementing a trial involving vulnerable children living in remote rural settings in a lower middle income endemic country has not been an easy task; over 7900 screening visits have been conducted and 444 patients were enrolled in the study. Our study is an example of how a public-private collaborative partnership can promote capacity-building and high-quality pediatric clinical research on neglected tropical diseases in sub-Saharan Africa.

The success of this trial has been built up through a solid team spirit, and experienced and very motivated people who continue to be extremely committed towards making a pediatric PZQ formulation available to the very young patients infected with schistosomiasis.

With this objective in mind, the Pediatric PZQ team is currently preparing for the confirmatory Phase III trial in schistosoma-infected preschool-age children.  Co-funded by the Consortium, the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Global Health Innovative Technology (GHIT) Fund, this clinical study will be implemented in Ivory Coast and Kenya and is planned to start in the second quarter of 2019.