NCT00988325

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
6 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 years until next milestone

Results Posted

Study results publicly available

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

September 30, 2009

Results QC Date

February 18, 2016

Last Update Submit

January 30, 2017

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

  • Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate

    Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate

    Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate

    Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

Secondary Outcomes (14)

  • Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/-15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate

    15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1

  • +9 more secondary outcomes

Study Arms (3)

Oseltamivir 3 mg

EXPERIMENTAL

infants 3 to \<12 months

Drug: Tamiflu

Oseltamivir 2.5 mg

EXPERIMENTAL

infants 1 to \<3 months of age

Drug: Tamiflu

Oseltamivir 2 mg

EXPERIMENTAL

infants 0 to 30 days (post natal) of age

Drug: Tamiflu

Interventions

TamifluDRUG

oral repeating dose

Oseltamivir 2 mgOseltamivir 2.5 mgOseltamivir 3 mg

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique

Bron, 69677, France

Location

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

Berlin, 13353, Germany

Location

LWL-Klinik-Bochum

Bochum, 44792, Germany

Location

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

Worms, 67547, Germany

Location

Fondazione Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Vitamed

Bydgoszcz, 85-021, Poland

Location

Samodzielny Publiczny Zakład Opieki; Wcześniaków I Intensywnej Terapii

Bydgoszcz, 85-168, Poland

Location

Zespol Opieki Zdrowotnej Debica; Oddzial Dzieciecy

Dębica, 39-200, Poland

Location

St Hedwig Hospital In Trzebnica

Trzebnica, 55-100, Poland

Location

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

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario de Getafe; Servicio de Pediatria

Madrid, Madrid, 28905, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26015411DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 20, 2017

Results First Posted

March 20, 2017

Record last verified: 2017-01

Locations

ES(2)BE(1)PL(4)FR(1)DE(3)IT(1)