A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
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Purpose
This 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, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Drug: Tamiflu |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years |
- Safety: AEs, vital signs, electrocardiograms, laboratory parameters [ Time Frame: AEs, vital signs: throughout study; electrocardiograms: days 1, 3, end of study; laboratory parameters: days 1, 3, after last intravenous infusion, end of study ] [ Designated as safety issue: No ]
- Pharmacokinetics [ Time Frame: Days 1, 3 ] [ Designated as safety issue: No ]
- Viral load and shedding [ Time Frame: Days 1, 4, 6, 11 ] [ Designated as safety issue: No ]
| Enrollment: | 118 |
| Study Start Date: | April 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Tamiflu
100 mg iv q12h for 5 days
|
| Active Comparator: 2 |
Drug: Tamiflu
200 mg iv q12h for 5 days
|
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult and adolescent patients, 13 years of age and older
- Diagnosis of influenza
- </=96 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 10-50 mL/min
Exclusion Criteria:
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
Contacts and Locations
Show 96 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01050257 History of Changes |
| Other Study ID Numbers: | NV25118 |
| Study First Received: | January 14, 2010 |
| Last Updated: | June 4, 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 June 13, 2013