EUCTR2006-002468-24-HU
Active, not recruiting
Phase 1
A double-blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza
ConditionsTo investigate the optimal therapy for influenza in immunocompromised patients.MedDRA version: 17.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsTamiflu
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- To investigate the optimal therapy for influenza in immunocompromised patients.
- Sponsor
- F.Hoffmann-La Roche Ltd.
- Enrollment
- 166
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\- 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)
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
Outcomes
Primary Outcomes
Not specified
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