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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01033734
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Drug: oseltamivir [Tamiflu] Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
    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.



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT01033734


Locations
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United States, California
Los Angeles, California, United States, 90095
Oakland, California, United States, 94609-1809
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, 02115
Boston, Massachusetts, United States, 02118
Springfield, Massachusetts, United States, 01199
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Duluth, Minnesota, United States, 55805
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Morristown, New Jersey, United States, 07960
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, 11794-8161
Syracuse, New York, United States, 13210
United States, North Carolina
Durham, North Carolina, United States, 27705
Raleigh, North Carolina, United States, 27610
United States, Ohio
Akron, Ohio, United States, 44308
Cleveland, Ohio, United States, 44106
Dayton, Ohio, United States, 45404
Toledo, Ohio, United States, 43606
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Tyrone, Pennsylvania, United States, 16686
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, South Carolina
Charleston, South Carolina, United States, 29524
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23298
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Israel
Petach Tikva, Israel, 19202
Lebanon
Beirut, Lebanon, 11-236
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033734    
Other Study ID Numbers: NP25139
First Posted: December 16, 2009    Key Record Dates
Results First Posted: August 24, 2016
Last Update Posted: August 24, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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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