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A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02623322
Recruitment Status : Completed
First Posted : December 7, 2015
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 7, 2015
Results First Submitted Date  ICMJE October 31, 2018
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE October 12, 2016
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline to Day 100 ]
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Baseline to Day 100 ]
  • Percentage of participants with anti-therapeutic antibodies (ATAs) to MHAA4549A [ Time Frame: From Baseline to Day 100 ]
Change History Complete list of historical versions of study NCT02623322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • Percentage of Participants Requiring Hospitalization for Influenza-Related Complications [ Time Frame: Baseline to Day 100 ]
  • Duration of Hospitalization for Influenza-Related Complications [ Time Frame: Baseline to Day 100 ]
  • Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections [ Time Frame: Baseline to Day 100 ]
    Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
  • Percentage of Participants With Complications of Influenza [ Time Frame: Baseline to Day 100 ]
    Participants with complications of influenza were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
  • Percentage of Participants With Influenza A Relapse/Reinfection [ Time Frame: Baseline to Day 100 ]
  • Area Under the Concentration-Time Curve (AUC) of MHAA4549A [ Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) ]
    The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL).
  • Maximum Serum Concentration (Cmax) of MHAA4549A [ Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) ]
  • Time to Alleviation of Symptoms of Influenza A Infection [ Time Frame: Baseline to Day 14 ]
    Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration.
  • Percentage of Participants With Influenza-Related Deaths [ Time Frame: Baseline to Day 100 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • Percentage of Participants Requiring Hospitalization for Influenza-Related Complications [ Time Frame: From Baseline to Day 100 ]
  • Duration of Hospitalization for Influenza-Related Complications [ Time Frame: From Baseline to Day 100 ]
  • Percentage of Participants Requiring Antibiotics for Secondary Bacterial Infections [ Time Frame: From Baseline to Day 100 ]
  • Percentage of Participants With Complications of Influenza [ Time Frame: From Baseline to Day 100 ]
  • Percentage of Participants With Influenza A Relapse/Reinfection [ Time Frame: From Baseline to Day 100 ]
  • Area Under the Concentration-Time Curve (AUC) of MHAA4549A [ Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose) ]
  • Maximum Serum Concentration (Cmax) of MHAA4549A [ Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose) ]
  • Time to alleviation of sign/symptoms of influenza A infection [ Time Frame: From Baseline to Day 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults
Brief Summary This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Influenza A
Intervention  ICMJE
  • Drug: MHAA4549A
    MHAA4549A will be administered as a single dose by IV administration.
  • Drug: Placebo
    Placebo will be administered as a single dose by IV administration.
Study Arms  ICMJE
  • Experimental: MHAA4549A 3600 milligrams (mg)
    Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.
    Intervention: Drug: MHAA4549A
  • Experimental: MHAA4549A 8400 mg
    Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
    Intervention: Drug: MHAA4549A
  • Placebo Comparator: Placebo
    Participants will receive single-dose placebo by IV administration.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2018)
124
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2015)
141
Actual Study Completion Date  ICMJE November 13, 2017
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Otherwise healthy participants
  • Positive test for influenza A infection
  • No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
  • Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
  • For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
  • For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration

Exclusion Criteria:

  • Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
  • Any significant medical conditions or laboratory abnormalities
  • Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
  • Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
  • Pregnancy at Screening or is currently pregnant or breastfeeding
  • Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
  • Prior anti-influenza monoclonal antibody use
  • Receipt of a nasal influenza A vaccine within 14 days prior to Screening
  • Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
  • History of significant tobacco use or drug/alcohol abuse
  • Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
  • Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
  • History of any chronic respiratory condition
  • Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months
  • Serious infection requiring oral or IV antibiotics within 14 days prior to Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   New Zealand,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623322
Other Study ID Numbers  ICMJE GV29893
2016-000425-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP