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A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection

NCT ID: NCT00988325

Last Updated: 2017-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[Tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oseltamivir 3 mg

infants 3 to \<12 months

Group Type EXPERIMENTAL

Tamiflu

Intervention Type DRUG

oral repeating dose

Oseltamivir 2.5 mg

infants 1 to \<3 months of age

Group Type EXPERIMENTAL

Tamiflu

Intervention Type DRUG

oral repeating dose

Oseltamivir 2 mg

infants 0 to 30 days (post natal) of age

Group Type EXPERIMENTAL

Tamiflu

Intervention Type DRUG

oral repeating dose

Interventions

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Tamiflu

oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infants \</=12 months of age
* laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
* influenza symptoms for \</=96 hours prior to first dose

Exclusion Criteria

* preterm infants less than 40 weeks (corrected for gestational age)
* weight less than 5th percentile for age (corrected for gestational age)
* concurrent gastrointestinal conditions that preclude enteric absorption of the drug
* bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
* active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
* symptomatic inborn errors of metabolism
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique

Bron, , France

Site Status

CAMPUS VIRCHOW-KLINIKUM CharitéCentrum 17 Klinik f.Pädiatrie Abt.Pneumologie u.Immunologie

Berlin, , Germany

Site Status

LWL-Klinik-Bochum

Bochum, , Germany

Site Status

Onkologische Schwerpunktpraxis Dr. Med. O. Burkhard & B. Reimann

Worms, , Germany

Site Status

Fondazione Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status

Vitamed

Bydgoszcz, , Poland

Site Status

Samodzielny Publiczny Zakład Opieki; Wcześniaków I Intensywnej Terapii

Bydgoszcz, , Poland

Site Status

Zespol Opieki Zdrowotnej Debica; Oddzial Dzieciecy

Dębica, , Poland

Site Status

St Hedwig Hospital In Trzebnica

Trzebnica, , Poland

Site Status

Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital Universitario de Getafe; Servicio de Pediatria

Madrid, Madrid, Spain

Site Status

Countries

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Belgium France Germany Italy Poland Spain

References

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Rath BA, Brzostek J, Guillen S, Niranjan V, Chappey C, Rayner CR, Clinch B. Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multicentre clinical trial. Antivir Ther. 2015;20(8):815-25. doi: 10.3851/IMP2967. Epub 2015 May 27.

Reference Type DERIVED
PMID: 26015411 (View on PubMed)

Other Identifiers

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2009-014365-12

Identifier Type: -

Identifier Source: secondary_id

WP22849

Identifier Type: -

Identifier Source: org_study_id

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