Treatment of Influenza MedDRA version: 17.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862 MedDRA version: 17.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862 MedDRA version: 17.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862
Conditions
Interventions
Product Name: MHAA4549A
Product Code: MHAA4549A/RO6876802
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: MHAA4549A/RO687680
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women = 18 years of age • Diagnosis of influenza A as determined by Sponsored-supplied rapid influenza test. If negative rapid influenza A test, a positive local molecular test (PCR) is required • Requirement for oxygen supplementation to maintain SpO2 >92% or PPV within 24 hours of hospital admission • Negative urine or serum pregnancy test for women of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 134
Exclusion criteria
Exclusion criteria: • Pregnant or lactating, or intending to become pregnant during the study • Hypersensitivity to monoclonal antibodies or any constituents of study drug • Investigational therapy within 30 days prior to study treatment • Received prior therapy with any anti-influenza monoclonal antibody therapy including MHAA4549A 8 months prior to study treatment • Onset of influenza symptoms >5 days prior to study treatment • Patients who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy (e.g., oral oseltamivir, inhaled zanamivir, or oral ribavirin) in the period from onset of symptoms and prior to enrollment • Requiring home or baseline oxygenation therapy • Positive influenza B or influenza A+B infection within 2 weeks prior to study treatment • Admission >48 hours prior to study treatment • Any disease or condition that would, in the opinion of the investigator or Sponsor, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the time to normalization of respiratory function of patients dosed with MHAA4549A in combination with oseltamivir compared to patients dosed with placebo and oseltamivir.;Secondary Objective: • To measure clinical failure after 24 hours post-infusion of study drug • To determine the time to clinical resolution of vital signs • To measure mortality in patients • To determine changes in the extent and duration of viral shedding in upper respiratory samples • To measure the duration of hospital and/or intensive care unit stay • To measure antibiotic usage for respiratory indications • To measure the frequency and severity of secondary complications of influenza • To measure duration of positive pressure ventilation • To measure readmission rates • To characterize the PK profile of MHAA4549A in serum ;Primary end point(s): Median time to normalization of respiratory function;Timepoint(s) of evaluation of this end point: The time to normalization of respiratory function will be defined as the time to removal of the patient from oxygen supplementation in order to maintain an oxygen saturation >95%. The analysis of this endpoint will be conducted at the end of the study after all patients have completed all study assessments and the database has been cleaned and closed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with clinical failure 24 hours post-infusion of study drug • Median time to clinical normalization of vital signs • Hazard ratio for mortality at Day 14, Day 30 and Day 60. • Mean and median AUC of viral load • Mean and median peak viral load • Median duration of viral shedding in upper respiratory samples • Median duration of hospitalization • Median duration of ICU stay • Proportion of patients requiring antibiotics for respiratory indications during study • Proportion of patients with influenza secondary complications • Median duration of ventilation • Proportion of patients who are readmitted by Day 30 and Day 60;Timepoint(s) of evaluation of this end point: All secondary endpoint analyses of the total study population will be conducted at the end of the study after all patients have completed all study assessments and the database has been cleaned and closed. | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
GENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
Outcome results
None listed