This chapter summarizes the clinical development of praziquantel (PZQ) and its active enantiomer (R)-PZQ focusing on the clinical studies that were performed to support their registration for the treatment and/or prophylaxis of infections due to different Schistosoma species. It begins with a general description of the three different clinical trial phases (I, II, and III) is given. Thereafter, the phase I and the phase II/III trials done for registering PZQ for patients suffering from infections with Schistosoma mansoni, S. haematobium, and S. japonicum in the 1980s are summarized. This is followed by a summary of the more recent trials performed for registering the child-friendly (R)-PZQ dispersible tablet formulation consisting of a phase I trial in healthy volunteers followed by a phase II and a phase III trials in infected children from 3 months to 6 years of age.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Clinical Efficacy of Praziquantel on Schistosoma Infections

  • Wilhelmina M. Bagchus

摘要

This chapter summarizes the clinical development of praziquantel (PZQ) and its active enantiomer (R)-PZQ focusing on the clinical studies that were performed to support their registration for the treatment and/or prophylaxis of infections due to different Schistosoma species. It begins with a general description of the three different clinical trial phases (I, II, and III) is given. Thereafter, the phase I and the phase II/III trials done for registering PZQ for patients suffering from infections with Schistosoma mansoni, S. haematobium, and S. japonicum in the 1980s are summarized. This is followed by a summary of the more recent trials performed for registering the child-friendly (R)-PZQ dispersible tablet formulation consisting of a phase I trial in healthy volunteers followed by a phase II and a phase III trials in infected children from 3 months to 6 years of age.