A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

October 15, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 81520-060
        • Hospital Erasto Gaertner
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital São Lucas da PUCRS
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
      • São Paulo, SP, Brazil, 08270-070
        • Casa de Saude Santa Marcelina
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital For Sick Children; Infectious Disease Dept
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University; Montreal Children's Hospital; Oncology
  • Chile
      • Viña del Mar, Chile, 2520000
        • Hospital Dr. Gustavo Fricke
  • Colombia
      • Cali, Colombia
        • Centro Médico Imbanaco
      • Cali, Colombia
        • Fundacion Clinica Valle de Lili, Department Rheumatology
  • Finland
      • Turku, Finland, 20520
        • Turun yliopistollinen keskussairaala
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • München, Germany, 80337
        • Dr. von Haunersches Kinderspital
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin
  • Greece
      • Athens, Greece, 115 27
        • Childrens Regional Hospital Aglaia Kyriakou
      • Athens, Greece, 11527
        • Aghia Sophia Children's Hospital; Pediatric Rheumatology Unit; 1st Department of Pediatrics
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Petach Tikva, Israel, 49100
        • Schneider Children's Medical Center of Israel; Pediatrics Department
      • Ramat-Gan, Israel, 52621
        • The Chaim Sheba Medical Center; Multiple Sclerosis Center
      • Tel Aviv, Israel, 64239
        • The Dana Children's Hospital
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00165
        • Ospedale Pediatrico Bambino Gesù
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa Pediatria 1
      • Monza, Lombardia, Italy, 20052
        • ASST DI MONZA; Divisione Malattie Infettive
  • Mexico
      • Mexico, Mexico, 04530
        • Instituto Nacional de Pediatria; Departmento de Neurologia
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Olsztyn, Poland, 10-561
        • Children Hospital, Olsztyn; Ward of Pediatric Hematology and Oncology
      • Szczecin, Poland, 71-242
        • Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego
      • Zabrze, Poland, 41-800
        • Medical University of Silesia; Department of Pediatric Hematology and Oncology
  • South Africa
      • Cape Town, South Africa, 7500
        • Tygerberg Hospital; Rheumatology
      • Johannesburg, South Africa, 1501
        • WWCT Lakeview Hospital
      • Johannesburg, South Africa, 2013
        • Chris Hani Baragwanath Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 280146
        • Hospital Universitario La Paz
    • Barcelona
      • Esplugues De Llobregas, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Child Hosp; Pediatric Pulmonary Division
    • Colorado
      • Aurora, Colorado, United States, 80045
        • The Children's Hospital; Pediatric Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female children, <13 years of age
  • Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
  • Immunocompromised
  • Symptoms/signs suggestive of influenza like illness (ILI)
  • Less than or equal to (</=) 96 hours between onset of ILI and first dose of study drug

Exclusion Criteria:

  • Clinical evidence of severe hepatic impairment
  • Infants with post-menstrual age (PMA) <36 weeks
  • Clinical evidence of significant renal impairment
  • Allergy to oseltamivir or excipients
  • Hereditary fructose intolerance
  • Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oseltamivir: Standard dose
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).
Drug: Oseltamivir
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 ) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
Other Names:
  • Tamiflu
Experimental: Oseltamivir: Triple dose
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.
Drug: Oseltamivir
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 ) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
Other Names:
  • Tamiflu

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
Trough Plasma Concentration (Ctrough) of Oseltamivir
Time Frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
Ctrough of Oseltamivir Carboxylate
Time Frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
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)
From randomization to negative PCR/culture test result (up to Day 50)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
From randomization to resolution of all influenza symptoms (up to Day 50)
Number of Participants With Adverse Events
Time Frame: Baseline up to Day 50
Baseline up to Day 50
Number of Participants With Influenza Associated Complications
Time Frame: Baseline up to Day 50
Baseline up to Day 50
Number of Participants With Viral Resistance
Time Frame: Baseline up to Day 50
Baseline up to Day 50
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
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
Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NV25719
  • 2012-002633-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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