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-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Male or female immunocompromised patients below or equal to 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
- Secondary Outcome Measures
Name Time Method