Study comparing MHAA4549A in combination with oseltamivir versus placebo in combination with oseltamivir for the treatment of severe influenza A infectio

Phase 1

Conditions: Treatment of Influenza
MedDRA version: 19.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862
MedDRA version: 19.0Level: LLTClassification code 10016790Term: FluSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 19.0Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862

Registration Number: EUCTR2014-000461-43-DE

Lead Sponsor: Genentech Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

• Men or women = 18 years of age
• 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 PCR test
• 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 130

Exclusion Criteria

• Pregnant or lactating, or intending to become pregnant during the study
• Hypersensitivity to monoclonal antibodies or to any constituents (sodium succinate, sucrose, polysorbate 20) of MHAA4549A study drug
• Hypersensitivity to the active substance or to any excipients of oseltamivir
• Investigational therapy within 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
• Onset of influenza symptoms >5 days prior to study treatment
• Patients who have taken more than a total of 6 doses (3 doses of peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir,laninamivir, peramivir) in the period from onset of symptoms and prior to study treatment
• 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