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).
Phase 1
- Conditions
- Treatment of influenza in immunocompromised paedriatric patients.MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-002633-11-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
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
Patients with hepatic decompensation, renal impairment or recent treatment with anti-viral medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- 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<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Time to cessation of influenza symptoms <br>- Time to cessation of influenza treatment <br>- Incidence/severity of adverse events <br>- Frequency/duration of influenza associated complications<br>- Pharmacodynamic measures including viral shedding, viral resistance, viral clearance curve;Timepoint(s) of evaluation of this end point: End of study