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A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01033734
First received: December 15, 2009
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Condition Intervention Phase
Influenza
Drug: oseltamivir [Tamiflu]
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics 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 (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1 [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion. ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2 [ Time Frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3 [ Time Frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4 [ Time Frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5 [ Time Frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1 [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2 [ Time Frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3 [ Time Frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4 [ Time Frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5 [ Time Frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion ] [ Designated as safety issue: No ]
  • Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values [ Time Frame: Baseline, Day 1, 6 and 30 ] [ Designated as safety issue: No ]
    IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.


Enrollment: 8
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: oseltamivir [Tamiflu]
5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children, 1-12 years of age
  • diagnosis of influenza
  • duration of influenza symptoms </=96 hours prior to first dose of study drug

Exclusion Criteria:

  • evidence of severe hepatic decompensation
  • patients taking probenecid within 1 week prior to first dose of study drug
  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: NCT01033734

  Show 38 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033734     History of Changes
Other Study ID Numbers: NP25139 
Study First Received: December 15, 2009
Results First Received: January 15, 2016
Last Updated: July 13, 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 December 02, 2016