A study comparing treatments of severe influenza A
Research type
Research Study
Full title
A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION
IRAS ID
159181
Contact name
Mark Bellamy
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2014-000461-43
Duration of Study in the UK
1 years, 10 months, 15 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of a new drug called MHAA4549A, which will be used in combination with an existing drug called oseltamivir in patients with severe influenza A. Currently, there is a great need in hospitalised influenza patients for a treatment that is well tolerated, can rapidly resolve influenza-related signs and symptoms, decrease mortality, reduce hospital and intensive care unit stays, as well as have a prolonged window for initiation of treatment beyond the current standard of care which is within 48 hours of the onset of flu symptoms. The efficacy of MHAA4549A will be tested with oseltamivir compared to oseltamivir alone. Approximately 334 patients will take part in this study across 170 centres globally (about 7 centres in the UK). To participate in this study patients must be 18 and over and have Influenza A infection. All patients will receive oseltamivir for a minimum of 5 days (10 doses) and will be followed up for 60 days from the time of study drug administration. MHAA4549A or placebo will be administered by IV infusion as a one off dose on the first day of treatment. Assessments for this study will include physical examinations, respiratory assessments, blood and urine samples and respiratory tract samples. The study is Sponsored by Genentech, Inc.
REC name
East of England - Essex Research Ethics Committee
REC reference
14/EE/1235
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion