A study in children and young adults with weak immunity and influenza (flu) infection to understand how the study drug (Tamiflu) improves the recovery from influenza (flu).

An open label, randomised, adaptive, multicenter, pharmacokinetic/pharmacodynamic, phase Ib, study of oseltamivir (Tamiflu®) in the treatment of influenza in immunocompromised children, between 0-18 years of age, with confirmed influenza infection.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002633-11-ES

Enrollment

Registered

2012-10-22

Start date

2013-01-24

Completion date

Unknown

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of influenza in immunocompromised paedriatric patients. MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Tamiflu Pharmaceutical Form: Capsule, hard INN or Proposed INN: OSELTAMIVIR CAS Number: 204255-11-8 Current Sponsor code: RO64-0796 Other descriptive name: Oseltamivir phosphate Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female immunocompromised patients below 18 years of age with confirmed influenza (flu) infection Are the trial subjects under 18? yes Number of subjects for this age range: 21 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with hepatic decompensation, renal impairment or recent treatment with anti-viral medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To estimate the pharmacokinetics (PK) of oseltamivir and OC for each of the three dose levels of oseltamivir in immunocompromised children with confirmed influenza infection, through the application of established population PK models to the sparse plasma concentration data generated - To examine the duration of viral shedding across each of the three dose levels and across OC exposures;Secondary Objective: - To examine the duration of influenza symptoms across each of the three dose levels of oseltamivir and across OC exposures - To examine the safety, tolerability and incidence of influenza associated complications across each of the three dose levels and across OC exposures;Primary end point(s): Pharmacokinetic measures of study drug.;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: - To estimate the pharmacokinetics (PK) of oseltamivir and OC for each of the three dose levels of oseltamivir in immunocompromised children with confirmed influenza infection, through the application of established population PK models to the sparse plasma concentration data generated - To examine the duration of viral shedding across each of the three dose levels and across OC exposures;Secondary Objective: - To examine the duration of influenza symptoms across each of the three dose levels of oseltamivir and across OC exposures - To examine the safety, tolerability and incidence of influenza associated complications across each of the three dose levels and across OC exposures;Primary end point(s): Pharmacokinetic measures of study drug.;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): - Time to cessation of influenza symptoms - Time to cessation of influenza treatment - Incidence/severity of adverse events - Frequency/duration of influenza associated complications - Pharmacodynamic measures including viral shedding, viral resistance, viral clearance curve;Timepoint(s) of evaluation of this end point: End of study	—

Countries

Belgium, Canada, Finland, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026