<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028909</url>
  </required_header>
  <id_info>
    <org_study_id>D6000C00003</org_study_id>
    <nct_id>NCT03028909</nct_id>
  </id_info>
  <brief_title>Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.</brief_title>
  <official_title>A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study are to determine if MEDI8852 administered with standard of care&#xD;
      (oseltamivir) will reduce the time to normalization of respiratory function for adults who&#xD;
      are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an&#xD;
      acceptable safety profile in adults who are hospitalized with influenza caused by Type A&#xD;
      strains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous&#xD;
      (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult&#xD;
      subjects who are hospitalized with influenza caused by Type A strains. Approximately 450&#xD;
      subjects will be enrolled at study centers in North America, Europe, and other regions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study is withdrawn due to company decision.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 24, 2017</start_date>
  <completion_date type="Anticipated">July 26, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of efficacy as defined as time to normalization of respiratory function.</measure>
    <time_frame>Through Day 14</time_frame>
    <description>To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The occurence of Adverse Events</measure>
    <time_frame>Through Day 28</time_frame>
    <description>Occurrence of adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The occurence of Serious Adverse Events</measure>
    <time_frame>Through Study Day 60</time_frame>
    <description>Occurrence of serious adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The occurence of Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Through Day 60</time_frame>
    <description>Occurrence of Adverse Events of Special Interest.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the effect of MEDI8852 in reducing severity of clinical status.</measure>
    <time_frame>Through Day 7</time_frame>
    <description>Evaluation of the effect of MEDI8852 in reducing severity of clinical status defined by death, ICU, non-ICU hospitalization, but requiring supplemental oxygen, non-ICU hospitalization and not requiring supplemental oxygen, not hospitalized, but unable to resume normal activities, fully resumed normal activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of time to hospital discharge.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>Evaluation of time to hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitation of influenza viral shedding by qRT-PCR.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>Evaluation of the effect of MEDI8852 in reducing the duration and quantity of viral shedding measured by qRT-PCR over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of serum concentrations and PK of MEDI8852.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate serum concentration of MEDI8852 through Day 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of serum ADA responses in serum through Day 60.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate the ADA response through Day 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of time to ICU discharge.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>Evaluation of time to ICU discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.</measure>
    <time_frame>Through Day 14</time_frame>
    <description>To evaluate time to clinical resolution of vital sign abnormalities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Change in NEWS from baseline through Day 14.</measure>
    <time_frame>Through Day 14</time_frame>
    <description>To evaluate the effect of MEDI8852 in reducing NEWS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate duration of mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate the rate of ICU admission from the general ward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation to determine the effect of MEDI8852 on all-cause mortality</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate All-cause mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.</measure>
    <time_frame>Through Day 60</time_frame>
    <description>To evaluate the rate of all-cause re-admission during the study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Influenza - Type A Strains</condition>
  <arm_group>
    <arm_group_label>Oseltamivir + low dose MEDI8852</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low Dose of MEDI8852 + Oseltamivir will be studied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oseltamivir + high dose MEDI8852</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose of MEDI8852 + Oseltamivir will be studied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oseltamivir + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oseltamivir in conjunction with placebo will be studied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oseltamivir</intervention_name>
    <description>Standard of care for influenza caused by Type A strains</description>
    <arm_group_label>Oseltamivir + Placebo</arm_group_label>
    <arm_group_label>Oseltamivir + high dose MEDI8852</arm_group_label>
    <arm_group_label>Oseltamivir + low dose MEDI8852</arm_group_label>
    <other_name>Tamiflu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI8852</intervention_name>
    <description>MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.</description>
    <arm_group_label>Oseltamivir + high dose MEDI8852</arm_group_label>
    <arm_group_label>Oseltamivir + low dose MEDI8852</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Salt-water solution containing no active ingredients.</description>
    <arm_group_label>Oseltamivir + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 18 years or older at the time of screening. Written informed consent and any locally&#xD;
        required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in&#xD;
        the United States, Data Privacy Directive in Europe) obtained from the subject/legal&#xD;
        representative prior to performing any protocol related procedures, including screening&#xD;
        evaluations.&#xD;
&#xD;
        Females of childbearing potential who are sexually active with a nonsterilized male partner&#xD;
        must have evidence of not being pregnant upon enrollment and have a negative pregnancy test&#xD;
        prior to administration of investigational product. Females of childbearing potential are&#xD;
        defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral&#xD;
        oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12&#xD;
        months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior&#xD;
        to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid&#xD;
        antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase&#xD;
        chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144&#xD;
        hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to&#xD;
        participate in the study through Day 60.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of study drugs or interpretation of subject safety or study results.&#xD;
&#xD;
          -  Concurrent enrollment in another clinical study involving an investigational&#xD;
             treatment. -Hospitalized &gt; 72 hours (&gt; 3 days) prior to receipt of a positive&#xD;
             diagnostic test for influenza A.&#xD;
&#xD;
          -  Receipt of &gt; 72 hours or &gt; 6 doses of treatment with a neuraminidase (NA) inhibitor.&#xD;
             -Receipt of any investigational antiviral medications within 30 days prior to study&#xD;
             drug dosing.&#xD;
&#xD;
          -  Previous receipt of an influenza mAb within past 100 days.&#xD;
&#xD;
          -  Pregnant or nursing female.&#xD;
&#xD;
          -  History of allergic disease or reactions likely to be exacerbated by any components of&#xD;
             the study drugs (MEDI8852 or oseltamivir).&#xD;
&#xD;
          -  Diagnosis of influenza B infection within 14 days prior to randomization.&#xD;
&#xD;
          -  Employees of the sponsor, clinical study site, or any other individuals involved with&#xD;
             the conduct of the study, or immediate family members of such individuals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza A</keyword>
  <keyword>MEDI8852</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Sprains and Strains</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oseltamivir</mesh_term>
    <mesh_term>MEDI8852</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028909
org study id: D6000C00003
nct id: NCT03028909
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purposes of this study are to determine if MEDI8852 administered with standard of care
      (oseltamivir) will reduce the time to normalization of respiratory function for adults who
      are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an
      acceptable safety profile in adults who are hospitalized with influenza caused by Type A
      strains.
The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous
      (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult
      subjects who are hospitalized with influenza caused by Type A strains. Approximately 450
      subjects will be enrolled at study centers in North America, Europe, and other regions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluation of efficacy as defined as time to normalization of respiratory function.
time frame: Through Day 14
description: To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function.
measure: The occurence of Adverse Events
time frame: Through Day 28
description: Occurrence of adverse events.
measure: The occurence of Serious Adverse Events
time frame: Through Study Day 60
description: Occurrence of serious adverse events.
measure: The occurence of Adverse Events of Special Interest (AESIs)
time frame: Through Day 60
description: Occurrence of Adverse Events of Special Interest.
measure: Assessment of the effect of MEDI8852 in reducing severity of clinical status.
time frame: Through Day 7
description: Evaluation of the effect of MEDI8852 in reducing severity of clinical status defined by death, ICU, non-ICU hospitalization, but requiring supplemental oxygen, non-ICU hospitalization and not requiring supplemental oxygen, not hospitalized, but unable to resume normal activities, fully resumed normal activities
measure: Evaluation of time to hospital discharge.
time frame: Through Day 60
description: Evaluation of time to hospital discharge.
measure: Quantitation of influenza viral shedding by qRT-PCR.
time frame: Through Day 60
description: Evaluation of the effect of MEDI8852 in reducing the duration and quantity of viral shedding measured by qRT-PCR over time.
measure: Evaluation of serum concentrations and PK of MEDI8852.
time frame: Through Day 60
description: To evaluate serum concentration of MEDI8852 through Day 60.
measure: Evaluation of serum ADA responses in serum through Day 60.
time frame: Through Day 60
description: To evaluate the ADA response through Day 60.
measure: Evaluation of time to ICU discharge.
time frame: Through Day 60
description: Evaluation of time to ICU discharge.
measure: Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.
time frame: Through Day 14
description: To evaluate time to clinical resolution of vital sign abnormalities.
measure: Evaluation of Change in NEWS from baseline through Day 14.
time frame: Through Day 14
description: To evaluate the effect of MEDI8852 in reducing NEWS.
measure: Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.
time frame: Through Day 60
description: To evaluate duration of mechanical ventilation.
measure: Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.
time frame: Through Day 60
description: To evaluate the rate of ICU admission from the general ward.
measure: Evaluation to determine the effect of MEDI8852 on all-cause mortality
time frame: Through Day 60
description: To evaluate All-cause mortality.
measure: Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.
time frame: Through Day 60
description: To evaluate the rate of all-cause re-admission during the study.
arm group label: Oseltamivir + low dose MEDI8852
arm group type: Experimental
description: Low Dose of MEDI8852 + Oseltamivir will be studied
arm group label: Oseltamivir + high dose MEDI8852
arm group type: Experimental
description: High dose of MEDI8852 + Oseltamivir will be studied.
arm group label: Oseltamivir + Placebo
arm group type: Active Comparator
description: Oseltamivir in conjunction with placebo will be studied.
intervention type: Drug
intervention name: Oseltamivir
description: Standard of care for influenza caused by Type A strains
arm group label: Oseltamivir + Placebo
arm group label: Oseltamivir + high dose MEDI8852
arm group label: Oseltamivir + low dose MEDI8852
other name: Tamiflu
intervention type: Drug
intervention name: MEDI8852
description: MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
arm group label: Oseltamivir + high dose MEDI8852
arm group label: Oseltamivir + low dose MEDI8852
intervention type: Drug
intervention name: Placebo
description: Salt-water solution containing no active ingredients.
arm group label: Oseltamivir + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Sprains and Strains
mesh term: Oseltamivir
mesh term: MEDI8852