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 hospitalized
patients requiring oxygen with severe influenza A in combination with oseltamivir versus
placebo with oseltamivir. A Sponsor-supplied rapid influenza test and/or a local polymerase
chain reaction (PCR) test must be used as an aid in the diagnosis of influenza A infection.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Men or women >/= 18 years of age on day of signing informed consent or obtaining
surrogate consent from an authorized representative
- Diagnosis of influenza A where one or both of the following are used as aid(s) in
diagnosis: a Sponsor-supplied rapid influenza test, a local molecular PCR test
- One of the following markers of severity within 24 hours of admission: requirement
for O2 supplementation to maintain SpO2 >92% or positive pressure ventilation
- A negative urine or serum pregnancy test for women of childbearing potential within 2
days prior to study treatment
- Patients of reproductive potential must agree to use acceptable contraceptive
measures as per the protocol as a minimum, and local guidelines, if more stringent
Exclusion Criteria:
- Pregnant or lactating, or intending to become pregnant during the study
- Hypersensitivity to monoclonal antibodies or any constituents of study drug
- Hypersensitivity to the active substance or to any excipients of oseltamivir
- Investigational therapy within the 30 days prior to study treatment
- Received prior therapy with any anti-influenza monoclonal antibody therapy including
MHAA4549A 8 months prior to study treatment
- Current treatment (within 7 days of dosing) with amantadine or rimantidine
- Patients who have taken more than a total of 3 days (6 doses) of approved
anti-influenza therapy (i. e., oral oseltamivir, inhaled zanamivir, or oral ribavirin)
in the period from onset of symptoms and prior to enrollment
- Admission > 48 hours prior to study treatment
- Onset of influenza symptoms > 5 days prior to study treatment
- Positive influenza B or influenza A + B infection within 2 weeks prior to study
treatment
- High probability of mortality in the next 48 hours as determined by the investigator
- Patient requiring home or baseline oxygenation therapy
- Patient with history of chronic lung disease resulting in baseline SpO2 < 95%
- Patient on chronic dose of corticosteroids exceeding 10 mg/day of prednisone or
equivalent steroid dose for a duration of greater than 14 days within 30 days of
entry into study
- Patients with the following significant immune suppression: bone marrow or solid
organ transplant in the previous 12 months; cancer chemotherapy in the previous 12
months, HIV infection with most recent CD4 < 200 cells/mL, or other significant
immune suppression as determined by the investigator in discussion with the Sponsor
Medical Monitor or representative
- Patient on extracorporeal membrane oxygenation at time of randomization
- Any disease or condition that would, in the opinion of the site investigator or
Sponsor, place the subject at an unacceptable risk of injury or render the subject
unable to meet the requirements of the protocol
Reference Study ID Number: GV29216 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com
Brussels 1000, Belgium; Recruiting
Brussels 1070, Belgium; Recruiting
Leuven 3000, Belgium; Recruiting
Yvoir 5530, Belgium; Recruiting
Gabrovo 5300, Bulgaria; Recruiting
Plovdiv 4005, Bulgaria; Not yet recruiting
Ruse 7002, Bulgaria; Recruiting
Sofia 1407, Bulgaria; Not yet recruiting
Sofia 1336, Bulgaria; Recruiting
Sofia 1606, Bulgaria; Recruiting
Sofia 1606, Bulgaria; Not yet recruiting
Varna 9010, Bulgaria; Not yet recruiting
Santiago 833033, Chile; Not yet recruiting
Temuco 4781151, Chile; Recruiting
Vina del Mar 2540364, Chile; Not yet recruiting
Brno 62500, Czech Republic; Not yet recruiting
Hradec Kralove 500 05, Czech Republic; Recruiting
Liberec 460 63, Czech Republic; Recruiting
Ostrava 708 52, Czech Republic; Recruiting
Praha 10 100 34, Czech Republic; Recruiting
Argenteuil 95107, France; Recruiting
Dijon 21079, France; Not yet recruiting
La Roche Sur Yon 85025, France; Recruiting
Limoges 87043, France; Recruiting
Nice 6202, France; Recruiting
Paris 75014, France; Recruiting
Strasbourg 67000, France; Recruiting
Strasbourg 67098, France; Recruiting
Tours 37044, France; Recruiting
Frankfurt 60590, Germany; Not yet recruiting
Halle 06120, Germany; Not yet recruiting
Heidelberg 69120, Germany; Not yet recruiting
Koeln 50931, Germany; Recruiting
Mainz 55131, Germany; Not yet recruiting
Tuebingen 72076, Germany; Not yet recruiting
Hong Kong, Hong Kong; Recruiting
Kistarcsa 2143, Hungary; Recruiting
Szolnok 5000, Hungary; Recruiting
Veszprém 8200, Hungary; Recruiting
Vác 2600, Hungary; Recruiting
Zalaegerszeg 8900, Hungary; Not yet recruiting
Busan 602-739, Korea, Republic of; Recruiting
Incheon, Korea, Republic of; Recruiting
Seoul 152-703, Korea, Republic of; Recruiting
Seoul 136-705, Korea, Republic of; Recruiting
Seoul 150-950, Korea, Republic of; Recruiting
Seoul 120-752, Korea, Republic of; Recruiting
Wonju 220-701, Korea, Republic of; Not yet recruiting
Leiden 2300 ZA, Netherlands; Not yet recruiting
Nijmegen 6500 HB, Netherlands; Recruiting
Rotterdam 3000 CA, Netherlands; Not yet recruiting
Rotterdam 3083AN, Netherlands; Not yet recruiting
Utrecht 3508 GA, Netherlands; Not yet recruiting
Zwolle 8025 AB, Netherlands; Not yet recruiting
Auckland 1124, New Zealand; Recruiting
Christchurch 8005, New Zealand; Recruiting
Tauranga 3143, New Zealand; Recruiting
Arequipa 54, Peru; Not yet recruiting
Cuzco 84, Peru; Not yet recruiting
La Victoria Lima 13, Peru; Not yet recruiting
LIma Lima 01, Peru; Not yet recruiting
Lima Lima 29, Peru; Not yet recruiting
Lima Lima 18, Peru; Not yet recruiting
Lima Lima 32, Peru; Not yet recruiting
Lima Lima 41, Peru; Not yet recruiting
Lima Lima 10, Peru; Not yet recruiting
Piura 20001, Peru; Not yet recruiting
San Juan de Miraflores LIMA 29, Peru; Not yet recruiting
Trujillo 13011, Peru; Not yet recruiting
Lublin 20-718, Poland; Not yet recruiting
Szczecin 70-111, Poland; Not yet recruiting
Toruń 87-100, Poland; Not yet recruiting
Łódź 91-347, Poland; Not yet recruiting
Chelyabinsk 454000, Russian Federation; Not yet recruiting
Engels 413124, Russian Federation; Not yet recruiting
St.Petersburg 194044, Russian Federation; Not yet recruiting
Vladivostok 690002, Russian Federation; Not yet recruiting
Parktown West 2196, South Africa; Not yet recruiting
Pretoria 0084, South Africa; Not yet recruiting
Worcester 6850, South Africa; Not yet recruiting
Barcelona 08035, Spain; Recruiting
Barcelona 08907, Spain; Recruiting
Granada 18012, Spain; Recruiting
Madrid 28905, Spain; Recruiting
Madrid 28040, Spain; Recruiting
Tarragona 43005, Spain; Recruiting
Valencia 46026, Spain; Recruiting
Göteborg 41650, Sweden; Not yet recruiting
Mamö 205 02, Sweden; Not yet recruiting
Umeå 901 85, Sweden; Not yet recruiting
Uppsala 751 85, Sweden; Not yet recruiting
Birmingham B9 5SS, United Kingdom; Recruiting
Birmingham B15 2TH, United Kingdom; Recruiting
Glasgow G42 9TY, United Kingdom; Not yet recruiting
Leeds LS1 3EX, United Kingdom; Not yet recruiting
London WC1E 6AU, United Kingdom; Not yet recruiting
London SE5 9RS, United Kingdom; Recruiting
Southampton SO16 6YD, United Kingdom; Recruiting
Stoke-On-Trent ST4 6QG, United Kingdom; Recruiting
Taunton TA1 5DA, United Kingdom; Not yet recruiting
Calgary, Alberta T2N 4Z6, Canada; Not yet recruiting
Terrassa, Barcelona 08221, Spain; Recruiting
Brescia, Basilicata, Italy; Not yet recruiting
New Westminster, British Columbia V3L 3W7, Canada; Not yet recruiting
Vancouver, British Columbia V6Z 1Y6, Canada; Recruiting
Victora, British Columbia V8Z 6R5, Canada; Not yet recruiting
Victoria, British Columbia V8R 1J8, Canada; Recruiting
Barcelona, Cantabria 08036, Spain; Recruiting
Mataro, Cantabria 08304, Spain; Recruiting
Bologna, Emilia-Romagna 40127, Italy; Not yet recruiting
Modena, Emilia-Romagna 41125, Italy; Not yet recruiting
Rome, Lazio 149, Italy; Not yet recruiting
Cremona, Lombardia 26100, Italy; Not yet recruiting
Milano, Lombardia 20127, Italy; Not yet recruiting
Belo Horizonte, MG 30150-221, Brazil; Not yet recruiting
London, Ontario N6A 5A5, Canada; Recruiting
Oshawa, Ontario L1G 2B9, Canada; Not yet recruiting
Ottawa, Ontario K1H8L6, Canada; Recruiting
Ottawa, Ontario K1Y 4E9, Canada; Not yet recruiting
Toronto, Ontario M4C 3E7, Canada; Not yet recruiting
Sainte-foy, Quebec G1V 4G2, Canada; Recruiting
Passo Fundo, RS 99010-080, Brazil; Not yet recruiting
Porto Alegre, RS 90035-001, Brazil; Not yet recruiting
Campinas, SP 13060-904, Brazil; Not yet recruiting
Sao Jose do Rio Preto, SP 15090-000, Brazil; Not yet recruiting
Sao Paulo, SP 01323-020, Brazil; Not yet recruiting
São Paulo, SP 04020-060, Brazil; Not yet recruiting
Vila Clementino, SP 04038-905, Brazil; Not yet recruiting
Salerno, Sardegna 84131, Italy; Not yet recruiting