A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

Summary

The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.

Timeline

Start

2016-12-08

Primary completion

2017-04-04

Completion

2017-04-24

Outcome

Mixed primary results

registry analysis (superiority test); Baloxavir vs Placebo; p <0.0001; Difference -26.5 (95% CI -35.8 to -17.8) NCT02954354 ↗

registry analysis (superiority test); Baloxavir vs Oseltamivir; p = 0.7560; Difference -0.3 (95% CI -6.6 to 6.6) NCT02954354 ↗

Publications

• Results Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
• Retout S, De Buck S, Jolivet S, Duval V, Cosson V. A Pharmacokinetics-Time to Alleviation of Symptoms Model to Support Extrapolation of Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B. Clin Pharmacol Ther. 2022 Aug;112(2):372-381. doi: 10.1002/cpt.2648. Epub 2022 Jun 10.
• Uehara T, Hayden FG, Kawaguchi K, Omoto S, Hurt AC, De Jong MD, Hirotsu N, Sugaya N, Lee N, Baba K, Shishido T, Tsuchiya K, Portsmouth S, Kida H. Treatment-Emergent Influenza Variant Viruses With Reduced Baloxavir Susceptibility: Impact on Clinical and Virologic Outcomes in Uncomplicated Influenza. J Infect Dis. 2020 Jan 14;221(3):346-355. doi: 10.1093/infdis/jiz244.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baloxavir Marboxil	Unknown	40 mg	Oral
Subject	Baloxavir Marboxil	Unknown	80 mg	Oral
Comparator	Oseltamivir	Small molecule	75 mg	Oral

Indications