A study to assess the safety of Oseltamivir administered in the vein forthe treatment of flu (Influenza) in patients of at least 13 years of age.

Conditions: Treatment of Influenza [seasonal or pandemic (H1N1) 2009]
MedDRA version: 14.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2010-020083-38-PL

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

• Male and female adults and adolescents, 13 years of age and older, except in Germany and Denmark, where the subjects enrolled should be 18 years of age or older.
• In France, patients enrolled into the renal impairment arm must be 18 years of age or older.
• Diagnosis of influenza (in Spain, Denmark and Germany: severe influenza requiring hospitalization) by virology testing or clinical diagnosis based on symptoms suggestive of influenza
• In Spain, Denmark and Germany: Hospitalized patients or requiring hospitalization and/or who are medically evaluated to not be good candidates for oral treatment and/or who might benefit from the IV administration of oseltamivir.
• Less than or equal to 144 hours between the onset of influenza-like illness and first dose of study medication
• Patient is willing and able to comply with study requirements and give consent, or, if applicable, consent may be given by a parent, legal guardian or legal representative
• Except in Spain, Denmark, and Germany: Patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus
• Except in Spain and Denmark: Patients who are lactating may be enrolled only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant. In Germany, patients who are
lactating must also be unable to receive oral oseltamivir.
• In Spain and Denmark: Subjects who are in the reproductive age group and sexually active must agree to utilize and an effective method of contraception throughout the study period and for one reproductive cycle following cessation of the study therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 11
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 149
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Patients with clinical evidence of severe hepatic decompensation at the time of randomization (e.g., evidence of jaundice, ascites, hepatic encephalopathy, and coagulation disturbances-Child-Pugh score above 9).
• Electrocardiogram showing acute ischemia or significant arrhythmia
• Allergy to test medication
• Patients taking probenicid medication within 7 days before starting study medication
• Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization (for renally impaired patients: 4 weeks prior to first dose of study medication).
• In Germany: Pregnant women
• In Spain and Denmark: Pregnant and lactating women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of oseltamivir administered by intravenous infusion in the treatment of influenza [seasonal or pandemic (H1N1) 2009 influenza];Secondary Objective: • To evaluate the pharmacokinetics of oseltamivir and oseltamivir carboxylate following IV administration of oseltamivir in patients with influenza<br>• To evaluate viral load and shedding<br>• To evaluate all isolates for phenotypic and, where necessary, genotypic resistance;Primary end point(s): The primary endpoints for safety will be assessments of adverse events, laboratory tests, vital signs and ECG measurements;Timepoint(s) of evaluation of this end point: Adverse Events are evaluated throughout the study. Vital signs are<br>evaluated at study visits Day 1, 6, 11, 15, 30 as well as at each IV dose.<br>Laboratory tests are on Day 1, Day 3 or 4, within 24 hours of last IV dose<br>and at Day 30. ECGs are before and after the 1st and 5th or 6th infusion<br>as well as at Day 30.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Occurrence or non-occurrence of shedding virus by culture<br>2) Occurrence or non-occurrence of shedding virus by RT-PCR<br>3) Viral load by culture<br>4) Body temperature<br>5) Absence or presence of fever, where fever is defined as a body<br>temperature = 37.8°C<br>6) Absence or presence of symptoms of influenza—for example, nasal<br>congestion, sore throat, cough, aches and pains, fatigue, headache or<br>chills/sweats (feverish), vomiting, diarrhea;Timepoint(s) of evaluation of this end point: 1) On Days 1, 4, 6, 11, 15 and 30<br>2) On Days 1, 4, 6, 11, 15 and 30<br>3) On Days 1, 4, 6, 11, 15, and 30<br>4) Twice daily<br>5) Twice daily<br>6) On Days 1, 11, 15 and 30<br>

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