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Clinical Trials/EUCTR2006-002468-24-DE
EUCTR2006-002468-24-DEActive, not recruitingPhase 1

A double-blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza

F.Hoffmann-La Roche Ltd.0 sites215 target enrollmentStarted: January 19, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
215
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

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 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: 57
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 65
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 44

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

Investigators

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