Treatment of Influenza [seasonal or pandemic (H1N1) 2009] MedDRA version: 14.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations Me
Conditions
Interventions
Product Name: Oseltamivir
Product Code: Ro 64-0796/F09-01
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Oseltamivir
CAS Number: 204255-11-8
Current Sponsor code: Ro 64-079
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria: • Patients with clinical evidence of severe hepatic decompensation at the time of randomization • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • To evaluate viral load and shedding • 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 evaluated at study visits Day 1, 6, 11, 15, 30 as well as at each IV dose. Laboratory tests are on Day 1, Day 3 or 4, within 24 hours of last IV dose and at Day 30. ECGs are before and after the 1st and 5th or 6th infusion as well as at Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Occurrence or non-occurrence of shedding virus by culture 2) Occurrence or non-occurrence of shedding virus by RT-PCR 3) Viral load by culture 4) Body temperature 5) Absence or presence of fever, where fever is defined as a body temperature = 37.8°C 6) Absence or presence of symptoms of influenza—for example, nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills/sweats (feverish), vomiting, diarrhea;Timepoint(s) of evaluation of this end point: 1) On Days 1, 4, 6, 11, 15 and 30 2) On Days 1, 4, 6, 11, 15 and 30 3) On Days 1, 4, 6, 11, 15, and 30 4) Twice daily 5) Twice daily 6) On Days 1, 11, 15 and 30 | — |
Countries
Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Romania, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed