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CompletedNCT01033734Updated Aug 24, 2016Results posted

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

A Phase 1 interventional study of oseltamivir [Tamiflu] in Influenza, sponsored by Hoffmann-La Roche. Completed at 38 sites in 3 countries. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2016-08-24.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
1 Year to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza

Browse trials for

03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 8 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • evidence of severe hepatic decompensation
  • patients taking probenecid within 1 week prior to first dose of study drug
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Single arm

    Drug: oseltamivir [Tamiflu]

Interventions

  • Drugoseltamivir [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.

06

What researchers measure

Primary outcomes

  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 outcomes

  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

    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.

    Time frame: Baseline, Day 1, 6 and 30

07

Results

Posted Aug 24, 2016
Limitations and caveats
Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.

Participant flow

Participant flow — Overall Study
MilestoneOseltamivir: Overall
Started8
Completed7
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryArea 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.
Reported as:
Geometric mean · hour*nanogram/milliliter (h*ng/mL)
Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
hour*nanogram/milliliter (h*ng/mL)Oseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir8291460 ± 46.3—
Oseltamivir Carboxylate17004550 ± 61.1—
PrimaryAUClast 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
Reported as:
Geometric mean · h*ng/mL
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
h*ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir—10701920
Oseltamivir Carboxylate—59706760
PrimaryAUClast 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
Reported as:
Geometric mean · hr*ng/mL
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3
hr*ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir943——
Oseltamivir Carboxylate2000——
PrimaryAUClast 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
Reported as:
Geometric mean · hr*ng/mL
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
hr*ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir—2480—
Oseltamivir Carboxylate—3800—
PrimaryAUClast 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
Reported as:
Geometric mean · hr*ng/mL
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5
hr*ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir1010——
Oseltamivir Carboxylate2820——
PrimaryMaximum 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
Reported as:
Geometric mean · nanograms/milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1
nanograms/milliliter (ng/mL)Oseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir360753 ± 36.9—
Oseltamivir Carboxylate311499 ± 55.1—
PrimaryCmax of Oseltamivir and Oseltamivir Carboxylate Day 2
Time frame:
Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Reported as:
Geometric mean · ng/mL
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2
ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir—5001270
Oseltamivir Carboxylate—663725
PrimaryCmax 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
Reported as:
Geometric mean · ng/mL
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3
ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir404——
Oseltamivir Carboxylate237——
PrimaryCmax of Oseltamivir and Oseltamivir Carboxylate Day 4
Time frame:
Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Reported as:
Geometric mean · ng/mL
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4
ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir—915—
Oseltamivir Carboxylate—549—
PrimaryCmax of Oseltamivir and Oseltamivir Carboxylate Day 5
Time frame:
Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Reported as:
Geometric mean · ng/mL
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5
ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Oseltamivir403——
Oseltamivir Carboxylate408——
SecondaryTime 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
Reported as:
Geometric mean · hours
Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
hoursOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Day 1: Oseltamivir (n = 1, 3, 0)2.001.26 ± 41.7NA ± NA
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)4.004.61 ± 53.3NA ± NA
Day 2: Oseltamivir (n = 0, 1, 1)NA ± NA2.00 ± NA1.00
Day 2: Oseltamivir Carboxylate (n = 0, 1, 1)NA ± NA4.62 ± NA6.00
Day 3: Oseltamivir (n = 1, 0, 0)1.05NA ± NANA ± NA
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)3.05NA ± NANA ± NA
Day 4: Oseltamivir (n = 0, 1, 0)NA ± NA2.50 ± NANA ± NA
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)NA ± NA8.05 ± NANA ± NA
Day 5: Oseltamivir (n = 1, 0, 0)2.00NA ± NANA ± NA
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)4.08NA ± NANA ± NA
SecondaryLast 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
Reported as:
Geometric mean · ng/mL
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
ng/mLOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Day 1: Oseltamivir (n = 1, 3, 0)4.402.41 ± 80.6NA ± NA
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)237308 ± 74.4NA ± NA
Day 2: Oseltamivir (n = 0, 2, 1)NA ± NA25.2 ± 1704911.24.76
Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)NA ± NA319 ± 0.44484
Day 3: Oseltamivir (n = 1, 0, 0)2.60NA ± NANA ± NA
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)149NA ± NANA ± NA
Day 4: Oseltamivir (n = 0, 1, 0)NA ± NA25.1 ± NANA ± NA
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)NA ± NA549 ± NANA ± NA
Day 5: Oseltamivir (n = 1, 0, 0)15.1NA ± NANA ± NA
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)339NA ± NANA ± NA
SecondaryTime 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
Reported as:
Geometric mean · hours
Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
hoursOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Day 1: Oseltamivir (n = 1, 3, 0)7.4210.50 ± 23.4NA ± NA
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)7.4211.98 ± 0.2NA ± NA
Day 2: Oseltamivir (n = 0, 2, 1)NA ± NA3.50 ± 448.512.00
Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)NA ± NA3.50 ± 448.4712.00
Day 3: Oseltamivir (n = 1, 0, 0)10.13NA ± NANA ± NA
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)10.13NA ± NANA ± NA
Day 4: Oseltamivir (n = 0, 1, 0)NA ± NA8.05 ± NANA ± NA
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)NA ± NA8.05 ± NANA ± NA
Day 5: Oseltamivir (n = 1, 0, 0)7.92NA ± NANA ± NA
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)7.92NA ± NANA ± NA
SecondaryElimination 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

No measurements were reported for this outcome.

SecondaryTotal 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

No measurements were reported for this outcome.

SecondaryVolume 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

No measurements were reported for this outcome.

SecondaryParticipants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values

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.

Time frame:
Baseline, Day 1, 6 and 30
Reported as:
Number · Participants
Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
ParticipantsOseltamivir: OverallOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Day 1 (n=6, 2, 3, 1)1010
Day 6 (n=1, 0, 1, 0)1NA1NA
Day 30 (n=1, 1, 0, 0)00NANA

Adverse events

Collected over Up to 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oseltamivir: Overall—2/8 (25%)5/8 (62.5%)
Oseltamivir: 6 to 12 Years—1/2 (50%)0/2 (0%)
Oseltamivir: 3 to 5 Years—1/5 (20%)4/5 (80%)
Oseltamivir: 1 to 2 Years—0/1 (0%)1/1 (100%)
Most frequent serious events
Most frequent serious events
EventOseltamivir: OverallOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
BronchospasmRespiratory, thoracic and mediastinal disorders1/81/20/50/1
SepsisInfections and infestations1/80/21/50/1
PyrexiaGeneral disorders1/80/21/50/1
Most frequent other events
Most frequent other events
EventOseltamivir: OverallOseltamivir: 6 to 12 YearsOseltamivir: 3 to 5 YearsOseltamivir: 1 to 2 Years
Drug Withdrawal SyndromeGeneral disorders1/80/20/51/1
Left Ventricular DysfunctionCardiac disorders1/80/21/50/1
Catheter Site ErosionGeneral disorders1/80/21/50/1
Device ExpulsionGeneral disorders1/80/21/50/1
Infusion Site ErythemaGeneral disorders1/80/21/50/1
Body Temperature IncreasedInvestigations1/80/21/50/1
CoughRespiratory, thoracic and mediastinal disorders1/80/21/50/1
RhinorrhoeaRespiratory, thoracic and mediastinal disorders1/80/21/50/1
Ingrowing NailSkin and subcutaneous tissue disorders1/80/21/50/1
Pain of SkinSkin and subcutaneous tissue disorders1/80/21/50/1

Baseline characteristics

All-participants population included all participants who were enrolled in the study.

Age, Continuous
Age, Continuous(years)Oseltamivir: Overall
Mean4.8 ± 3.1
Sex: Female, Male
Sex: Female, Male(Participants)Oseltamivir: Overall
Female2
Male6
08

Study locations

38 sites
  • Los Angeles, California 90095, United States
  • Oakland, California 94609-1809, United States
  • Aurora, Colorado 80045, United States
  • Wilmington, Delaware 19803, United States
  • Jacksonville, Florida 32209, United States
  • Chicago, Illinois 60611, United States
  • South Bend, Indiana 46601, United States
  • Wichita, Kansas 67214, United States
  • Louisville, Kentucky 40202, United States
  • Boston, Massachusetts 02111, United States
  • Boston, Massachusetts 02115, United States
  • Boston, Massachusetts 02118, United States
  • Springfield, Massachusetts 01199, United States
  • Detroit, Michigan 48201, United States
  • Duluth, Minnesota 55805, United States
  • Omaha, Nebraska 68131, United States
  • Morristown, New Jersey 07960, United States
  • Bronx, New York 10461, United States
  • Brooklyn, New York 11203, United States
  • New York, New York 10016, United States
  • Stony Brook, New York 11794-8161, United States
  • Syracuse, New York 13210, United States
  • Durham, North Carolina 27705, United States
  • Raleigh, North Carolina 27610, United States
  • Akron, Ohio 44308, United States
  • Cleveland, Ohio 44106, United States
  • Dayton, Ohio 45404, United States
  • Toledo, Ohio 43606, United States
  • Toledo, Ohio 43608, United States
  • Oklahoma City, Oklahoma 73104, United States
  • Tyrone, Pennsylvania 16686, United States
  • Providence, Rhode Island 02903, United States
  • Charleston, South Carolina 29524, United States
  • Houston, Texas 77030, United States
  • Richmond, Virginia 23298, United States
  • Madison, Wisconsin 53792, United States
  • Petach Tikva, 19202, Israel
  • Beirut, 11-236, Lebanon
09

References and documents

Publications

  • Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307. PubMed 26042486 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01033734
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 16, 2009
Start date
Dec 2010
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Aug 24, 2016
Last update
Aug 24, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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