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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02293863




Registration number
NCT02293863
Ethics application status
Date submitted
14/11/2014
Date registered
18/11/2014
Date last updated
18/06/2018

Titles & IDs
Public title
A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection
Scientific title
Secondary ID [1] 0 0
2014-000461-43
Secondary ID [2] 0 0
GV29216
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MHAA4549A
Treatment: Drugs - Oseltamivir
Treatment: Drugs - Placebo

Experimental: A: MHAA4549A 3600 mg + Oseltamivir - Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

Experimental: B: MHAA4549A 8400 mg + Oseltamivir - Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

Placebo Comparator: C: Placebo + Oseltamivir - Participants 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.


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

Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization up to 60 days
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From randomization up to 60 days
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
From randomization up to 60 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Days 1-7, 14 and 30
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
From randomization up to 60 days
Secondary outcome [4] 0 0
Percentage of Participants Who Died Due to Any Cause
Timepoint [4] 0 0
Days 14, 30 and 60
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Duration of Hospitalization
Timepoint [8] 0 0
From randomization up to 60 days
Secondary outcome [9] 0 0
Duration of Intensive Care Unit (ICU) Stay
Timepoint [9] 0 0
From randomization up to 60 days
Secondary outcome [10] 0 0
Percentage of Participants Using Antibiotics for Respiratory Infections
Timepoint [10] 0 0
From randomization up to 60 days
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
From randomization up to 60 days
Secondary outcome [12] 0 0
Percentage of Participants Readmitted to Hospital Due to Any Cause
Timepoint [12] 0 0
Days 30 and 60
Secondary outcome [13] 0 0
Duration of Ventilation
Timepoint [13] 0 0
From randomization up to 60 days
Secondary outcome [14] 0 0
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).
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Maximum Serum Concentration (Cmax ) of MHAA4549A
Timepoint [15] 0 0
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)
Secondary outcome [16] 0 0
Elimination Half-Life (Terminal t1/2) of MHAA4549A
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Observed Clearance (CL-obs) of MHAA4549A
Timepoint [17] 0 0
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)
Secondary outcome [18] 0 0
Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A
Timepoint [18] 0 0
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)

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Mont-godinne
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Brazil
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MG
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Gabrovo
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Bulgaria
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Plovdiv
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Ruse
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Sevlievo
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Sofia
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Varna
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Bulgaria
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Veliko Tarnovo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Temuco
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Chile
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Vina del Mar
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Liberec
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Czechia
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Ostrava
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Czechia
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Praha 10
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France
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Argenteuil
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France
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Clermont-ferrand
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France
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Dijon
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France
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Garches
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France
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La Roche Sur Yon
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France
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Lille
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France
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Limoges
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France
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Nancy
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France
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Nice
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France
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Paris
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France
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Strasbourg
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France
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Tours
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Germany
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Frankfurt
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Mainz
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Germany
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Tuebingen
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Hong Kong
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Hong Kong
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Hungary
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Kistarcsa
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Hungary
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Veszprém
Country [47] 0 0
Hungary
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Vác
Country [48] 0 0
Hungary
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Zalaegerszeg
Country [49] 0 0
Israel
State/province [49] 0 0
Afula
Country [50] 0 0
Israel
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Beer-Sheva
Country [51] 0 0
Israel
State/province [51] 0 0
Holon
Country [52] 0 0
Israel
State/province [52] 0 0
Jerusalem
Country [53] 0 0
Israel
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Nahariya
Country [54] 0 0
Israel
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Nazareth
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Israel
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Petah Tikva
Country [56] 0 0
Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Israel
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Zefat
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Italy
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Basilicata
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Sardegna
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju
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Mexico
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Guadalajara
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Mexico
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Mexico, Distrito Federal
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Mexico
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Monterrey
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Mexico
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Tijuana
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Mexico
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Xalapa-enriquez
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Netherlands
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'S Hertogenbosch
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Netherlands
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Apeldoorn
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Netherlands
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Zwolle
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Tauranga
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Peru
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Cusco
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Peru
State/province [85] 0 0
Cuzco
Country [86] 0 0
Peru
State/province [86] 0 0
La Victoria
Country [87] 0 0
Peru
State/province [87] 0 0
LIma
Country [88] 0 0
Peru
State/province [88] 0 0
Lima
Country [89] 0 0
Peru
State/province [89] 0 0
Piura
Country [90] 0 0
Peru
State/province [90] 0 0
San Juan de Miraflores
Country [91] 0 0
Peru
State/province [91] 0 0
Trujillo
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Poland
State/province [92] 0 0
Lublin
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Poland
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Szczecin
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Poland
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Torun
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Poland
State/province [95] 0 0
Lódz
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Russian Federation
State/province [96] 0 0
Chelyabinsk
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Russian Federation
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Engels
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Russian Federation
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St.Petersburg
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Russian Federation
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Vladivostok
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South Africa
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Parktown West
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South Africa
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Pretoria
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South Africa
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Worcester
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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Granada
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Spain
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Madrid
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Spain
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Tarragona
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Spain
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Valencia
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Sweden
State/province [110] 0 0
Goteborg
Country [111] 0 0
Sweden
State/province [111] 0 0
Göteborg
Country [112] 0 0
Sweden
State/province [112] 0 0
Mamö
Country [113] 0 0
Sweden
State/province [113] 0 0
Umeå
Country [114] 0 0
Taiwan
State/province [114] 0 0
Kaohsiung
Country [115] 0 0
Taiwan
State/province [115] 0 0
New Taipei
Country [116] 0 0
Taiwan
State/province [116] 0 0
Taipei
Country [117] 0 0
Taiwan
State/province [117] 0 0
Taoyuan City
Country [118] 0 0
Ukraine
State/province [118] 0 0
Kyiv
Country [119] 0 0
Ukraine
State/province [119] 0 0
Odesa
Country [120] 0 0
Ukraine
State/province [120] 0 0
Poltava
Country [121] 0 0
Ukraine
State/province [121] 0 0
Zhytomyr
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Birmingham
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Glasgow
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Leeds
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Southampton
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Stoke-On-Trent
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02293863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications