NCT02293863

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	MHAA4549A	Participants will receive a single dose of MHAA4549A by IV infusion on Day 1
DRUG	Oseltamivir	Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir.
DRUG	Placebo	Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1

Timeline

• Start date: 2015-01-14
• Primary completion: 2017-05-23
• Completion: 2017-05-23
• First posted: 2014-11-18
• Last updated: 2018-06-18
• Results posted: 2018-06-18

Locations

171 sites across 25 countries: Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom