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AzTrials

InfluenzaPhase 2NCT02293863

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

A Phase 2 study testing MHAA4549A and Oseltamivir in people with Influenza, run by Genentech, Inc. at 171 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
MHAA4549A and Oseltamivir
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
171 sitesin 25 countries
Study dates
14 Jan 2015to 23 May 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of influenza A where a Sponsor-approved influenza test is used as an aid in diagnosis. A Sponsor-approved influenza test includes: Influenza antigen test or Influenza polymerase chain reaction (PCR) test
  • One of the following markers of severity within 24 hours of admission: requirement for O2 supplementation to maintain SpO2 greater than (>) 92 %; or requirement for Positive Pressure Ventilation (PPV)
  • A negative urine or serum pregnancy test for women of childbearing potential within 2 days prior to study treatment
  • Participants of reproductive potential must agree to use acceptable contraceptive measures as per the protocol as a minimum, and local guidelines, if more stringent

Who cannot join

  • Pregnant or lactating women, or women who intend to become pregnant during the study
  • Hypersensitivity to monoclonal antibodies or any constituents (sodium succinate, sucrose, polysorbate 20) 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) within 8 months prior to study treatment
  • Current treatment (within 7 days of dosing) with probenecid, amantadine or rimantidine
Show all 17Show fewer
  • Participants who have taken more than a total of 6 doses (3 doses for peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir, laninamivir, peramivir) in the period from onset of symptoms and prior to study treatment
  • Admission >48 hours prior to study treatment
  • Onset of influenza symptoms (including fever, chills, malaise, dry cough, loss of appetite, myalgias, coryza, or nausea) >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
  • Participants requiring home or baseline oxygenation therapy
  • Participants with history of chronic lung disease with a documented SpO2 less than (<) 95% off oxygen
  • Participants on chronic dose of corticosteroids exceeding 10 milligrams per day (mg/day) of prednisone or equivalent steroid dose for duration of greater than 14 days within 30 days of entry into study
  • Participants 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 Cluster of Differentiation 4 (CD4) <200 cells per milliliter (cells/mL), or other significant immune suppression as determined by the investigator in discussion with the Sponsor Medical Monitor
  • Participants on extracorporeal membrane oxygenation (ECMO) at time of randomization
  • Any disease or condition that would, in the opinion of the site investigator or Sponsor, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Trial locations and contacts

171 sites in 25 countries.

171 sites in 25 countries

Canada19 sites

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • Alberta Health Services

    Calgary, Alberta, T2N 4N2

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4Z6

  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

  • LHSC - University Hospital; Research Pharmacy

    London, Ontario, N6A 5A5

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Centre Hospitalier de la Universite Laval

    Québec, Quebec, G1V 4G5

  • Pavillion Chul-Chuq

    Sainte-Foy, Quebec, G1V 4G2

  • Toronto East General

    Toronto, Ontario, M4C 3E7

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Centre de santé et de services sociaux de Trois-Rivières

    Trois-Rivières, Quebec, G9A1Y1

  • St. Paul's Hospital, Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

  • Victoria General Hospital

    Victora, British Columbia, V8Z 6R5

  • Royal Jubilee Hospital Victoria general Hospital

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

France13 sites

  • CH Victor Dupouy

    Argenteuil, 95107

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, 63000

  • Service de Réanimation médicale - Bocage Central

    Dijon, 21079

  • APHP Raymond Poincare

    Garches, 92380

  • CHD Vendée

    La Roche-sur-Yon, 85025

  • CHRU Lille

    Lille, 59037

  • Réanimation Polyvalente, CHU Limoges

    Limoges, 87043

  • CHRU Nancy

    Nancy, 54035

  • Archet 1 university Hospital

    Nice, 6202

  • HOPITAL COCHIN university hospital

    Paris, 75014

  • Réanimation médicale NHC

    Strasbourg, 67000

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Service de réanimation médicale, Hôpital Bretonneau

    Tours, 37044

Other trials in France

Peru13 sites

  • Hospital Regional del Cusco

    Cusco, 84

  • Hospital Nacional Adolfo Guevara Velasco

    Cuzco, 84

  • Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

    La Victoria, Lima 13

  • Clinica Internacional Sede Lima

    Lima, Lima 01

  • Hospital Nacional; Arzobispo Loayza

    Lima, Lima 01

  • Hospital Nacional Hipolito; Unanue

    Lima, Lima 10

  • Hospital Central Fuerza; Aerea del Peru

    Lima, Lima 18

  • Hospital Maria Auxiliadora

    Lima, Lima 29

  • Clínica San Gabriel

    Lima, Lima 32

  • Clinica San Borja

    Lima, Lima 41

  • Hospital de la Amistad Peru Corea II-2 Santa Rosa

    Piura, 20001

  • Clinica Divino Nino Jesus; Orden de Malta

    San Juán de Miraflores, LIMA 29

  • Clinica Peruana Americana

    Trujillo, 13011

Other trials in Peru

Spain13 sites

  • Hospital Clinic

    Barcelona, Cantabria, 08036

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Bellvitge University Hospital

    Barcelona, 08907

  • Hospital Universitario San Cecilio

    Granada, 18012

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hospital Univ. de Getafe.Servicio de Neurologia

    Madrid, 28905

  • Hospital de Mataro

    Mataro, Cantabria, 08304

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Joan XXIII University Hospital

    Tarragona, 43005

  • Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Servicio de Medicina Intensiva Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

Bulgaria11 sites

  • MHAT "Dr. Tota Venkova"- Gabrovo

    Gabrovo, 5300

  • University Multiprofile Hospital for Active Treatment "St. George"

    Plovdiv, 4005

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    Rousse, 7002

  • Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD

    Sevlievo, 5400

  • MHAT Lyulin EAD, Department of internal diseases

    Sofia, 1336

  • MHAT TOKUDA SOFIA/ICU-Intensive Care Unit

    Sofia, 1407

  • 5th Multifunctional Hospital for Active treatment

    Sofia, 1606

  • Military Medical Academy- MHAT

    Sofia, 1606

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

    Sofia, 1606

  • MBAL St Marina Dep Pulmonology, ICU

    Varna, 9010

  • Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Israel11 sites

  • Haemek Medical Center

    Afula, 18101

  • Soroka University Medical Centre

    Beersheba, 84101

  • Wolfson Medical Center

    Holon, 58100

  • Hadasit Medical Research Services and Development Ltd

    Jerusalem, 91999

  • Galilee Medical Center

    Nahariya, 22100

  • Nazareth EMMS Hospital

    Nazareth, 16100

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7661041

  • Ziv Medical Center

    Safed, 1311001

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52661

Other trials in Israel

United Kingdom9 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Heart of England NHS Trust

    Birmingham, B9 5SS

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Leeds General Infirmary, Anaesthetic Department, D Floor

    Leeds, LS1 3EX

  • King College Hospital NHS Foundation Trust

    London, SE5 9RS

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, WC1E 6AU

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Netherlands8 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy

    Apeldoorn, 7334 DV

  • LUMC

    Leiden, 2300 ZA

  • UMC Radboud Nijmegen

    Nijmegen, 6500 HB

  • Erasmus Medical Centre; Department of Virology L-359

    Rotterdam, 3000 CA

  • Ikazia Hospital

    Rotterdam, 3083AN

  • UMCU

    Utrecht, 3508 GA

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

Italy7 sites

  • Clinic of Infectious Diseases

    Bologna, Emilia-Romagna, 40127

  • University Division of Infective and Tropical Diseases, University of Brescia, Italy

    Brescia, Basilicate

  • Asst Di Cremona

    Cremona, Lombardy, 26100

  • Ospedale San Raffaele - Milano

    Milan, Lombardy, 20127

  • University Hospital Modena, Intensive Care Unit

    Modena, Emilia-Romagna, 41125

  • National Institute for Infectious Diseases "L. Spallanzani"

    Rome, Lazio, 149

  • A.O.U. S. Giovanni di Dio e Ruggi d'Aragona

    Salerno, Sardinia, 84131

Other trials in Italy

South Korea7 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Gachon University Gil Hospital

    Incheon

  • Korea University Anam Hospital

    Seoul, 02841

  • Korea University Guro Hospital

    Seoul, 08308

  • Yonsei University Health System/Severance Hospital

    Seoul, 120-752

  • Hallym university Kangnam Sacred Heart Hospital; Infectious devision

    Seoul, 150-950

  • Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Brazil6 sites

  • Santa Casa de Misericordia; de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • PUC Campinas

    Campinas, São Paulo, 13060-904

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • FUNFARME

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Alemao Oswaldo Cruz; Oncologia

    São Paulo, São Paulo, 01323-020

  • Hospital Edmundo Vasconcelos

    Vila Clementino, São Paulo, 04038-905

Other trials in Brazil

Mexico6 sites

  • Hospital Civil de Guadalajara Dr Juan I Menchaca

    Guadalajara, 44280

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

    Mexico City, 14000

  • CEPREP; Hospital Universitario

    Monterrey, 64460

  • Hospital General de Tijuana

    Tijuana, 22320

  • Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio

    Xalapa, 91020

Other trials in Mexico

Czechia5 sites

  • The University Hospital Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Anesthesia and Intensive Care Dept., Regional Hospital Liberec

    Liberec, 460 63

  • University hospital Ostrava, Clinic of infectious medicine

    Ostrava, 708 52

  • Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace

    Prague, 100 34

Other trials in Czechia

Germany5 sites

  • Uniklinik Köln, Medizinischen Klinik I

    Cologne, 50931

  • Universitätsklinikum Frankfurt Goethe Universität

    Frankfurt, 60590

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Uniklinikum Mainz

    Mainz, 55131

  • Uniklinik Tübingen

    Tübingen, 72076

Other trials in Germany

Ukraine5 sites

  • Kyiv City Clinical Hospital #4

    Kyiv, 03110

  • Kyiv City Clinical Hospital #9

    Kyiv, 04060

  • Municipal Institution City Clinical Infectious Diseases Hospital

    Odesa, 65023

  • Poltava Regional Clinical Infectious Hospital

    Poltava, 36011

  • Municipal Institution Central City Hospital #1 City of Zhytomyr

    Zhytomyr, 10002

Other trials in Ukraine

Belgium4 sites

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • Hospital Erasme; Neurologie

    Brussels, 1070

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

Other trials in Belgium

Hungary4 sites

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2084

  • Jávorszky Ödön Hospital

    Vác, 2600

  • Csolnoky Ferenc Kórház

    Veszprém, 8200

  • Zala County Hospital ICU

    Zalaegerszeg, 8900

Other trials in Hungary

Poland4 sites

  • Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk

    Lodz, 91-347

  • Wojewodzki Szpital Specjalistyczny

    Lublin, 20-718

  • Icu Spsk - 2

    Szczecin, 70-111

  • Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera

    Torun, 87-100

Other trials in Poland

Russia4 sites

  • Municipal Clinical Hospital #8

    Chelyabinsk, 454000

  • Municipal Healthcare Institution "City Hospital №2"

    Engel's, 413124

  • Medical Military Academy n.a S.M.Kirov

    Saint Petersburg, 194044

  • Paciific state medical university

    Vladivostok, 690002

Other trials in Russia

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Uppsala University Hospital, Department of Infectious Diseases

    Gothenburg, 41650

  • Skånes Universitetssjukhus

    Mamö, 205 02

  • Norrland Universitetssjukhus

    Umeå, 901 85

Other trials in Sweden

Taiwan4 sites

  • Kaohsiung Medical University Hospital, Cancer Center

    Kaohsiung City, 807

  • Far East Memorial Hospital

    New Taipei City, 220

  • Wanfang Hospital

    Taipei, 116

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1124

  • Christchurch Hospital

    Christchurch, 8011

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

South Africa3 sites

  • Milpark Hospital

    Parktown West, 2196

  • Emmed Research

    Pretoria, 0084

  • Clinical Projects Research

    Worcester, 6850

Other trials in South Africa

Chile2 sites

  • Hospital Dr. Hernan Henriquez Aravena

    Temuco, 4781151

  • Clinica Renaca

    Viña del Mar, 2540364

Other trials in Chile

Hong Kong1 site

  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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
Influenza
Being tested
MHAA4549A, Oseltamivir, Placebo
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MHAA4549ADrug

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

  • OseltamivirDrug

    Also called Tamiflu

    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

Study groups in NCT02293863
Study groupRoleWhat they receive
A: MHAA4549A 3600 mg + OseltamivirExperimentalParticipants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
Receives: Drug: MHAA4549A; Drug: Oseltamivir
B: MHAA4549A 8400 mg + OseltamivirExperimentalParticipants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
Receives: Drug: MHAA4549A; Drug: Oseltamivir
C: Placebo + OseltamivirPlacebo comparatorParticipants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days.
Receives: Drug: Oseltamivir; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: From randomization up to 60 days

  2. Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A

    Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.

    Measured: From randomization up to 60 days

  3. Time to Normalization of Respiratory Function

    The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.

    Measured: From randomization up to 60 days

Secondary outcomes (18)

  1. Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome

    The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.

    Measured: Days 1-7, 14 and 30

  2. Percentage of Participants With Clinical Failure

    Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2-6 liters per minute [L/min]) to high flow oxygen (i.e., > 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by > 2 weeks, or death.

    Measured: 24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60

  3. Percentage of Participants With Clinical Resolution of Abnormal Vital Signs

    Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate < 24 breaths per minute without supplemental O2; 3. Core temperature < 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature > 36 C in participants who are initially hypothermic; 4. Heart rate (HR) < 100 beats/minute; 5. Systolic blood pressure (SBP) >90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.

    Measured: From randomization up to 60 days

  4. Percentage of Participants Who Died Due to Any Cause

    Measured: Days 14, 30 and 60

  5. Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus

    Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).

    Measured: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  6. Peak Influenza A Viral Load

    Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.

    Measured: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  7. Duration of Viral Shedding

    Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.

    Measured: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  8. Duration of Hospitalization

    Measured: From randomization up to 60 days

  9. Duration of Intensive Care Unit (ICU) Stay

    Measured: From randomization up to 60 days

  10. Percentage of Participants Using Antibiotics for Respiratory Infections

    Measured: From randomization up to 60 days

  11. Percentage of Participants With Secondary Complications of Influenza

    The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.

    Measured: From randomization up to 60 days

  12. Percentage of Participants Readmitted to Hospital Due to Any Cause

    Measured: Days 30 and 60

  13. Duration of Ventilation

    Measured: From randomization up to 60 days

  14. Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A

    AUC0-inf is reported as day*microgram/milliliter (day*mcg/mL).

    Measured: 30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  15. Maximum Serum Concentration (Cmax ) of MHAA4549A

    Measured: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  16. Elimination Half-Life (Terminal t1/2) of MHAA4549A

    Measured: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  17. Observed Clearance (CL-obs) of MHAA4549A

    Measured: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  18. Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A

    Measured: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study start14 Jan 2015
  3. Primary completion23 May 2017
  4. Study completion23 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293863
Sponsor's protocol ID
GV29216
Other IDs
2014-000461-43, 2014
Status last verified
May 2018
First submitted
14 Nov 2014
Last updated
18 Jun 2018

Publications

  • Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.

    PubMed 32393496

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MHAA4549A and Oseltamivir in people with Influenza, run by Genentech, Inc. at 171 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in Canada, France, Peru, Spain, Bulgaria and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: From randomization up to 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.

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