A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
연구 개요
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.
- 스폰서
- 리드: 로슈
- 적응증
- Influenza
- 중재
- Baloxavir Marboxil
- 목표 등록
- 1,100명
- 시작일
- 2023-11-22
- 완료(예정)
- 2027-06-30
BioPulse가 제공하는 정보는 공개된 자료를 요약·정리한 것으로, 투자 조언이나 의료 조언이 아닙니다. 임상 데이터·규제 일정·공시 내용은 반드시 원문을 직접 확인하시기 바랍니다.