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

NCT02293863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-06-18

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-14
Primary Completion
2017-05-23
Completion
2017-05-23

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

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293863 on ClinicalTrials.gov