A clinical trial testing usual dose and double dose oseltamivir (the medicine) in which neither the doctor or patient know what dose of medicine is given for treatment of influenza (the flu), in patients with a weakened immune (protective) system.

Phase 1

• Conditions: To investigate the optimal therapy for influenza in immunocompromised patients.; MedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-002468-24-BG
• Lead Sponsor: F.Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Age greater than or equal to 1 year
• Rapid diagnostic test, PCR, or viral culture positive for influenza
• Immunocompromised subject defined as one who meets any of the following:
- Primary immunodeficiency at risk for viral infections OR
- Secondary immunodeficiency
- SOT with ongoing immunosuppression OR
- Allogenic HSCT with ongoing immunosuppression
OR
- HIV with CD4 count < 500/mm3 and, in the investigator's opinion, considered immunocompromised OR
- Hematologic malignancies OR
- Systemic (e.g. enteric, sc, im or iv)
immunosuppressive therapy, irrespective of medical indication, started at least 12 weeks prior to, and ongoing at the time of first dose of study drug
• Symptoms suggestive of influenza like illness including, but not limited to fever, cough, or coryza
• Use of an effective contraceptive, as specified by protocol; women of
childbearing potential cannot be pregnant or breastfeeding.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 187
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

• Influenza vaccination with live attenuated vaccine in the 2 weeks prior
to randomization
• Antiviral treatment for influenza in 2 weeks prior to randomization
• Severe hepatic impairment
• Any current renal replacement therapy
• Any gastrointestinal disorders which may intefere with the absorption
of Tamiflu
• Participation in a study with an investigational drug from 4 weeks prior
to study start until study end

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified