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

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ClinicalTrials.gov Identifier: NCT00545532
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg]-75mg twice daily orally [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 throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Condition or disease Intervention/treatment Phase
Influenza, Human Drug: oseltamivir Other: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : February 4, 2008
Primary Completion Date : May 2, 2017
Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Conventional dose
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>=13 years old) or placebo-matched to oseltamivir twice daily over 10 days.
Drug: oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participants age and weight) po bid for 10 days
Other: placebo
Placebo matched to oseltamivir po bid for 10 days
Experimental: Double dose
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
Drug: oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participants age and weight) po bid for 10 days
Other: placebo
Placebo matched to oseltamivir po bid for 10 days


Outcome Measures

Primary Outcome Measures :
  1. Percentage of participants with adverse events [ Time Frame: Baseline up to Day 40 ]
  2. Percentage of participants who developed viral resistance to Tamiflu [ Time Frame: Baseline up to Day 40 ]
  3. Percentage of participants with tissue rejection or graft versus host disease (GVHD) [ Time Frame: Baseline up to Day 40 ]

Secondary Outcome Measures :
  1. Time to alleviation of all clinical influenza symptoms [ Time Frame: Baseline up to Day 40 ]
  2. Percentage of participants with viral shedding assessed by culture and reverse transcription polymerase chain reaction (RT-PCR) [ Time Frame: Baseline up to Day 40 ]
  3. Percentage of participants with viral load assessed by culture and RT-PCR [ Time Frame: Baseline up to Day 40 ]
  4. Percentage of participants who developed secondary illness (otitis media, bronchitis, pneumonia, or sinusitis) [ Time Frame: Baseline up to Day 40 ]
  5. Pharmacokinetics: Area under the concentration-time curve from 0 to 12 hours (AUC0-12) at steady state [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  6. Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  7. Pharmacokinetics: Trough plasma concentration (Ctrough) [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  8. Pharmacokinetics: Elimination half-life (t 1/2), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  9. Pharmacokinetics: Time to maximum concentration (tmax), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  10. Pharmacokinetics: Elimination constant (ke), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  11. Pharmacokinetics: Apparent clearance (CL/F), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  12. Pharmacokinetics: Apparent volume of distribution (Vc/F), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  13. Pharmacokinetics: Apparent total clearance of metabolite (CLm), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  14. Pharmacokinetics: Last measureable concentration (Clast), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  15. Pharmacokinetics: Time to last measureable concentration (tlast), if appropriate [ Time Frame: Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose ]
  16. Percentage of participants with each individual symptom score [ Time Frame: Day one up to Day 40 ]
  17. Percentage of participants who initiated antibiotic treatment [ Time Frame: Baseline up to Day 40 ]
  18. Percentage of participants who had been hospitalized [ Time Frame: Baseline up to Day 40 ]
  19. Duration of hospitalization [ Time Frame: Baseline up to Day 40 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
  • Immunocompromised participants 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 oseltamivir
  • Participation in a study with an investigational drug from 4 weeks prior to study start until study end
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545532


  Show 208 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545532     History of Changes
Other Study ID Numbers: NV20234
2006-002468-24 ( EudraCT Number )
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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