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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545532
First received: October 16, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 2-arm study will investigate the safety and tolerability of twice daily con ventional and double dose Tamiflu (oseltamivir) for the treatment of influenza i n immunocompromised patients. Eligible immunocompromised patients with laborator y-confirmed influenza will be randomized to receive either conventional dose (30 mg-75mg twice daily po, depending on age and weight) or double dose (60mg-150mg twice daily po depending on age and weight) Tamiflu for 10 days. Nasal and throa t swabs will be taken, and safety evaluations made, at intervals during the stud y. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.


Condition Intervention Phase
Influenza
Drug: oseltamivir
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 Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tissue rejection or graft versus host disease in transplant patients [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Development of viral resistance to Tamiflu [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 40 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • Development of secondary illnesses [ Time Frame: 40 days ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 166
Study Start Date: February 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional dose Tamiflu [Oseltamivir] Drug: oseltamivir
30-75 mg (depending on patients age and weight) po bid for 10 days
Experimental: Double dose Tamiflu [Oseltamivir] Drug: oseltamivir
60-150 mg (depending on patients age and weight) po bid for 10 days

  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, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
  • Immunocompromised patients with primary or secondary immunodeficiency
  • Symptoms suggestive of influenza-like illness
  • Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

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 interfere with the absorption of Tamiflu
  • Participation in a study with an investigational drug from 4 weeks prior to study start until study end
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545532

Contacts
Contact: Reference Study ID Number: NV20234 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 181 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: August 26, 2014
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 August 26, 2014