<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/NCT01715909</url>
  </required_header>
  <id_info>
    <org_study_id>NV25719</org_study_id>
    <secondary_id>2012-002633-11</secondary_id>
    <nct_id>NCT01715909</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection</brief_title>
  <official_title>An Open-Label, Randomized, Adaptive, Two-Arm, Multicenter Trial to Evaluate Pharmacokinetics And Pharmacodynamics of Two Doses of Oseltamivir (Tamiflu®) in The Treatment Of Influenza in Immunocompromised Children Less Than 13 Years Of Age, With Confirmed Influenza Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the&#xD;
      pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children,&#xD;
      less than (&lt;) 13 years of age, with confirmed influenza infection. Participants will be&#xD;
      randomized to receive either the standard dose or triple dose of oseltamivir orally daily for&#xD;
      a minimum of 5 days and up to 20 days. Infants &lt;1 year of age will be randomized to the&#xD;
      standard dose arm only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2014</start_date>
  <completion_date type="Actual">June 17, 2018</completion_date>
  <primary_completion_date type="Actual">June 17, 2018</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steady State Area Under the Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady State AUC0-12 of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough Plasma Concentration (Ctrough) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration) on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ctrough of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration) on Days 3 or 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cessation of Viral Shedding, as Assessed by Polymerase Chain Reaction (PCR) or Culture Testing</measure>
    <time_frame>From randomization to negative PCR/culture test result (up to Day 50)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Influenza Symptoms (including fever),, as Assessed by Canadian Acute Respiratory Infections Scale (CARIFS)</measure>
    <time_frame>From randomization to resolution of all influenza symptoms (up to Day 50)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Baseline up to Day 50</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Influenza Associated Complications</measure>
    <time_frame>Baseline up to Day 50</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Viral Resistance</measure>
    <time_frame>Baseline up to Day 50</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Rate Constant (Ke) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ke of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (V/F) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>V/F of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL/F) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Last Measurable Concentration (Tlast) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tlast of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Last Measurable Concentration (Clast) of Oseltamivir</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clast of Oseltamivir Carboxylate</measure>
    <time_frame>Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Oseltamivir: Standard dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight. Infants &lt;1 year of age will receive oseltamivir at a dose of 3 milligrams per kilogram (mg/kg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oseltamivir: Triple dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive three times the standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight and age. Infants &lt;1 year will receive standard dose at 3 mg/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oseltamivir</intervention_name>
    <description>Participants will receive standard dose (30 to 75 milligrams [mg]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for &lt;/= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (&gt;) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.</description>
    <arm_group_label>Oseltamivir: Standard dose</arm_group_label>
    <arm_group_label>Oseltamivir: Triple dose</arm_group_label>
    <other_name>Tamiflu</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female children, &lt;13 years of age&#xD;
&#xD;
          -  Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral&#xD;
             culture positive for influenza&#xD;
&#xD;
          -  Immunocompromised&#xD;
&#xD;
          -  Symptoms/signs suggestive of influenza like illness (ILI)&#xD;
&#xD;
          -  Less than or equal to (&lt;/=) 96 hours between onset of ILI and first dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence of severe hepatic impairment&#xD;
&#xD;
          -  Infants with post-menstrual age (PMA) &lt;36 weeks&#xD;
&#xD;
          -  Clinical evidence of significant renal impairment&#xD;
&#xD;
          -  Allergy to oseltamivir or excipients&#xD;
&#xD;
          -  Hereditary fructose intolerance&#xD;
&#xD;
          -  Received anti-viral treatment with activity against influenza (for example amantadine,&#xD;
             rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or&#xD;
             probenecid medication within 2 weeks prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lucile Packard Child Hosp; Pediatric Pulmonary Division</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital; Pediatric Infectious Diseases</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Lucas da PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Graacc-Grupo de Apoio ao adolescente e a crianca com cancer</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa de Saúde Santa Marcelina</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>08270-070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children'S Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital For Sick Children; Infectious Disease Dept</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University; Montreal Children's Hospital; Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Gustavo Fricke</name>
      <address>
        <city>Viña del Mar</city>
        <zip>2520000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Imbanaco</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Clinica Valle de Lili, Department Rheumatology</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turun yliopistollinen keskussairaala</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Von Haunersches Kinderspital</name>
      <address>
        <city>München</city>
        <zip>80337</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Regional Hospital Aglaia Kyriakou</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aghia Sophia Children's Hospital; Pediatric Rheumatology Unit; 1st Department of Pediatrics</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah University Hospital - Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel; Pediatrics Department</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center; Multiple Sclerosis Center</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dana Children's Hospital</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Pediatrico Bambino Gesu</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa Pediatria 1</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST DI MONZA; Divisione Malattie Infettive</name>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20052</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Pediatria; Departmento de Neurologia</name>
      <address>
        <city>Mexico</city>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children Hospital, Olsztyn; Ward of Pediatric Hematology and Oncology</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-561</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego</name>
      <address>
        <city>Szczecin</city>
        <zip>71-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Silesia; Department of Pediatric Hematology and Oncology</name>
      <address>
        <city>Zabrze</city>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tygerberg Hospital; Rheumatology</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WWCT Lakeview Hospital</name>
      <address>
        <city>Johannesburg</city>
        <zip>1501</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris Hani Baragwanath Hospital</name>
      <address>
        <city>Johannesburg</city>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan De Deu</name>
      <address>
        <city>Esplugues De Llobregas</city>
        <state>Barcelona</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Nino Jesus</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>280146</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Guatemala</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oseltamivir</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/NCT01715909
org study id: NV25719
secondary id: 2012-002633-11
nct id: NCT01715909
lead sponsor: 
This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the
      pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children,
      less than (<) 13 years of age, with confirmed influenza infection. Participants will be
      randomized to receive either the standard dose or triple dose of oseltamivir orally daily for
      a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized to the
      standard dose arm only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Steady State Area Under the Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Steady State AUC0-12 of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Maximum Plasma Concentration (Cmax) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Cmax of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Trough Plasma Concentration (Ctrough) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
measure: Ctrough of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
measure: Time to Cessation of Viral Shedding, as Assessed by Polymerase Chain Reaction (PCR) or Culture Testing
time frame: From randomization to negative PCR/culture test result (up to Day 50)
measure: Time to Resolution of Influenza Symptoms (including fever),, as Assessed by Canadian Acute Respiratory Infections Scale (CARIFS)
time frame: From randomization to resolution of all influenza symptoms (up to Day 50)
measure: Number of Participants With Adverse Events
time frame: Baseline up to Day 50
measure: Number of Participants With Influenza Associated Complications
time frame: Baseline up to Day 50
measure: Number of Participants With Viral Resistance
time frame: Baseline up to Day 50
measure: Half-life (t1/2) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: t1/2 of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Time to Maximum Concentration (Tmax) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Tmax of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Elimination Rate Constant (Ke) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Ke of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Apparent Volume of Distribution (V/F) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: V/F of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Apparent Clearance (CL/F) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: CL/F of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Time to Last Measurable Concentration (Tlast) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Tlast of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Last Measurable Concentration (Clast) of Oseltamivir
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
measure: Clast of Oseltamivir Carboxylate
time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
arm group label: Oseltamivir: Standard dose
arm group type: Experimental
description: Participants will receive standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight. Infants <1 year of age will receive oseltamivir at a dose of 3 milligrams per kilogram (mg/kg).
arm group label: Oseltamivir: Triple dose
arm group type: Experimental
description: Participants will receive three times the standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight and age. Infants <1 year will receive standard dose at 3 mg/kg.
intervention type: Drug
intervention name: Oseltamivir
description: Participants will receive standard dose (30 to 75 milligrams [mg]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for </= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
arm group label: Oseltamivir: Standard dose
arm group label: Oseltamivir: Triple dose
other name: Tamiflu
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Belgium
country: Brazil
country: Canada
country: Chile
country: Colombia
country: Finland
country: Germany
country: Greece
country: Israel
country: Italy
country: Mexico
country: Poland
country: South Africa
country: Spain
country: United States
country: Argentina
country: Guatemala
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Oseltamivir