A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01053663
First received: January 20, 2010
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.


Condition Intervention Phase
Influenza
Drug: Tamiflu
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate [ Time Frame: Multiple sampling day 3 or 4 ] [ Designated as safety issue: No ]
  • Safety Profile: AEs, vital signs, laboratory parameters [ Time Frame: Days 1-11 and on follow up days 15 and 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral load and shedding [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30 ] [ Designated as safety issue: No ]
  • Development of resistance to oseltamivir [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and at days 15 and 30 if samples are collected ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tamiflu
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6

  Eligibility

Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant patients
  • Date of birth to date of enrollment is <1 year
  • Diagnosis of influenza
  • Duration of influenza symptoms </=96 hours prior to first dose
  • - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)

Exclusion Criteria:

  • Date of conception to date of birth + date of birth to enrollment is <36 weeks
  • Creatinine clearance <30 mL/min/1.73m2
  • Patients receiving any form of renal replacement therapy at baseline
  • Clinical evidence of severe hepatic decompensation at the time of enrollment
  • Patients taking probenecid medication within 1 week prior to study day 1 or during the study
  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: NCT01053663

  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States, 45229-3039
United States, California
Los Angeles, California, United States, 90095
Oakland, California, United States, 94609-1809
Orange, California, United States, 92868
San Diego, California, United States, 92123
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, Florida
Jacksonville, Florida, United States, 32209
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Indiana
South Bend, Indiana, United States, 46601
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02118
Boston, Massachusetts, United States, 02115
Springfield, Massachusetts, United States, 01199
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Nevada
Syracuse, Nevada, United States, 13210
United States, New Jersey
Morristown, New Jersey, United States, 07960
New Brunswick, New Jersey, United States, 08901
United States, New York
Bronx, New York, United States, 10461
Brooklyn, New York, United States, 11203
New York, New York, United States, 10016
Stony Brook, New York, United States, 11794
United States, North Carolina
Durham, North Carolina, United States, 27705
Raleigh, North Carolina, United States, 27610
United States, Ohio
Akron, Ohio, United States, 44308-1062
Cleveland, Ohio, United States, 44106
Dayton, Ohio, United States, 45404
Toledo, Ohio, United States, 43608
Toledo, Ohio, United States, 43606
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, Texas
Austin, Texas, United States, 78723
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23219
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Israel
Petach Tikva, Israel, 49100
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: NCT01053663     History of Changes
Other Study ID Numbers: NP25138
Study First Received: January 20, 2010
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 August 28, 2014