CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
MHAA4549A +2 moredrug
Likely dose
Oseltamivir 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02293863
NCT02293863Phase 2Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Nov 18, 2014·Updated Jun 18, 2018

In Brief

A Phase 2 clinical trial evaluating MHAA4549A, Oseltamivir, and 1 other intervention for Influenza. Completed, enrolled 168 participants across 171 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBelgium, 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
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartJan 14, 2015
Primary CompletionMay 23, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.6 years ago

Interventions

MHAA4549Adrug

Participants will receive a single dose of MHAA4549A by IV infusion on Day 1

Oseltamivirdrug

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.

Placebodrug

Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1