A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412737
First received: December 15, 2006
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Condition Intervention Phase
Influenza
Drug: Oseltamivir
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.


Secondary Outcome Measures:
  • Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.

  • Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.

  • Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.

  • Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.

  • Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.

  • Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ] [ Designated as safety issue: No ]
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.


Enrollment: 477
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oseltamivir Drug: Oseltamivir
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Other Name: Tamiflu
Placebo Comparator: Placebo Drug: Placebo
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Negative rapid diagnostic test for influenza at baseline;
  • Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion Criteria:

  • Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
  • Influenza vaccination in 6 weeks prior to randomization;
  • Positive rapid diagnostic test for influenza;
  • Solid organ transplant within 6 months of randomization;
  • Antiviral treatment for influenza in 2 weeks prior to randomization.
  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: NCT00412737

  Show 78 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412737     History of Changes
Other Study ID Numbers: NV20235 
Study First Received: December 15, 2006
Results First Received: August 3, 2009
Last Updated: May 4, 2016
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2016