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

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: MHAA4549A (Drug); Oseltamivir [Tamiflu] (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
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


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.

Clinical Details


Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Safety: (composite outcome measure): Incidence of adverse events and clinical laboratory abnormalities

Time to normalization of respiratory function, defined as the time to cessation of O2 support resulting in a stable SpO2 >95% for at least 24 hours

Secondary outcome:

Proportion of patients with clinical failure 24 hours post-infusion defined by progression to increased O2 requirement, progression to ICU, prolonged ventilation or O2 support >2 weeks or death

Time to clinical resolution of vital signs

All-cause mortality at Day 14, Day 30, Day 60

Duration of viral shedding in upper respiratory samples

Duration of hospital / intensive care unit (ICU) stay

Proportion of patients requiring antibiotics for respiratory infections during study

Proportion of patients with secondary complications of influenza

Duration of ventilation

All-cause readmission at Day 30 and at Day 60

Pharmacokinetics (composite outcome measure): parameters derived from serum concentrations of MHAA4549A: area under the concentration-time curve (AUC), maximum observed concentration (Cmax), clearance, half-life, and volume of distribution


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


- 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

Locations and Contacts

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

Additional Information

Starting date: January 2015
Last updated: August 17, 2015

Page last updated: August 23, 2015

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