Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060194) titled 'XOFLUZA Granules 2% Individual Packets Specified Drug Use results Survey (Survey of patients weighing less than 10 kg)' on Jan. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Shionogi & Co., Ltd.
Condition:
Condition - influenza A or B virus infection
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To collect the safety and the efficacy of XOFLUZA Granules in patients weighing less than 10 kg under actual use conditions
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with influenza A or B virus infection weighing less than 10 kg who are receiving baloxavir marboxil for the first time
Key exclusion criteria - NA
Target Size - 45
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 02 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2027 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068849
Disclaimer: Curated by HT Syndication.
