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A Study of Tamiflu (Oseltamivir) for Treatment of Influenza in Immunocompromised Patients.

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545532
First received: October 16, 2007
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

This 2-arm study will investigate the safety and tolerability of twice daily conventional and high dose Tamiflu (oseltamivir) for the treatment of influenza in immunocompromised patients. Eligible immunocompromised patients with laboratory-confirmed influenza will be randomized to receive either conventional dose (30mg-75mg twice daily po, depending on age and weight) or high dose (60mg-150mg twice daily po depending on age and weight) Tamiflu for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study treatment is 10 days.


Condition Intervention Phase
Influenza
 Drug: oseltamivir
Other: Alternative Control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Stratified Multi-center Trial Evaluating Conventional and High Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety (incidence of adverse events) [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Development of viral resistance to Tamiflu [ Time Frame: 40 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to alleviation of all clinical influenza symptoms [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Proportion of viral shedding [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Development of secondary illnesses [ Time Frame: 40 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: February 1966
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: oseltamivir
60-150mg (depending on patients age and weight) po bid for 10 days
Active Comparator: 2 Drug: oseltamivir
30-75mg (depending on patients age and weight) po bid for 10 days
3 Other: Alternative Control
As a placebo control arm was considered unethical in this treatment population, an alternative control arm had to be identified for efficacy end points. The response to placebo in pivotal Tamiflu registration trials in the healthy adult population with influenza was chosen as a control in lieu of a placebo arm in the current trial. In order to do this, the end points were designed to be similar to that in the pivotal registration trials.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, >=1 year of age
  • Rapid diagnostic test positive for influenza in the 96 hours prior to first dose
  • Immunocompromised patients with primary or secondary immunodeficiency
  • Symptoms suggestive of influenza-like illness

Exclusion Criteria:

  • Solid organ transplant within 6 months of the time of randomization
  • Experienced acute rejection in the 4 weeks prior to randomization
  • Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
  • Antiviral treatment for influenza in 2 weeks prior to randomization
  • Any uncontrolled co-morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545532

Contacts
Contact: Please reference Study ID Number: NV20234 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 186 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545532     History of Changes
Other Study ID Numbers: NV20234
Study First Received: October 16, 2007
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013