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

Phase 1

Conditions: Treatment of influenza in immunocompromised paedriatric patients.
MedDRA version: 16.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-002633-11-FI

Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To generate data for the purpose of extrapolation of efficacy from adults with immunodeficiency and to compare and/or integrate exposure and response observations in the pediuatric immunocompromised population to that seen in other, non-immunocompromised populations.;Secondary Objective: To examine the safety, tolerability, incidence of influenza-associated complications, resistance and characterize any resistant virus isolates (in terms of sequence and phenotype) observed with different doses and duration of treatment.;Primary end point(s): - Pharmacokinetics: Area under the concentration-time curve (AUC)<br>- Pharmacodynamics: Time to cessation of viral shedding;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to resolution of influenza symptoms <br>- Incidence of adverse events <br>- Incidence of influenza associated complications<br>- Frequency of viral clearance;Timepoint(s) of evaluation of this end point: 24 months