Phase 3
N=118
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01050257 ↗Enrolled (actual)
118
Serious AEs
18.6%
Results posted
Nov 2013
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death — 1; 1; 3; 24 Partipants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oseltamivir IV (Drug); Oseltamivir Oral (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death |
1; 1; 3; 24; 27; 11 | — |
| SECONDARY Pharmacokinetics |
— | — |
| SECONDARY Percentage of Participants With Viral Shedding by Culture or RT-PCR |
90; 97; 90; 64; 75; 60 | — |
| SECONDARY Percentage of Participants With Viral Shedding by Culture |
76; 80; 90; 14; 29; 30 | — |
| SECONDARY Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
86; 93; 90; 64; 71; 60 | — |
| SECONDARY Change From Baseline in Influenza Titer by Culture at Day 4 |
-1.38; -2.19; -3.00 | — |
| SECONDARY Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4 |
-1.04; -1.30; -1.53; -0.70; -1.51; -2.27 | — |
| SECONDARY Percentage of Participants Who Had a Fever During the Study |
23; 19; 20; 7; 9; 10 | — |
| SECONDARY Time to Resolution of Fever for Participants Who Had a Fever at Baseline |
11.8; 18.6; 47.7 | — |
| SECONDARY Number of Participants With Viral Resistance |
1; 1; 0 | — |
| SECONDARY Percentage of Participants With Influenza Symptoms |
100; 100; 93; 63; 64; 79 | — |
Summary
This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.
Eligibility Criteria
Inclusion Criteria
- Adult and adolescent patients, 13 years of age and older
- Diagnosis of influenza
- ≤ 144 hours between the onset of influenza-like illness and first dose of study drug
Non-randomized, open-label treatment group:
- Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min
Exclusion Criteria
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
Data sourced from ClinicalTrials.gov (NCT01050257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.