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This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dose | Experimental | Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. |
|
| Double Dose | Active Comparator | Oseltamivir capsule will be administered orally at a dose of 150 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Excreting Resistant Virus | Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1). | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With A Reduction in Viral Load | Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load. | Baseline, Day 5 |
| Number of Participants With Various Clinical Signs and Symptoms |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curitiba | 80810-040 | Brazil | ||||
Out of 199 participants, 162 were considered as screening failures, mainly due to the negative result detected by the quick test for Influenza A Antigen. Therefore, 37 participants included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose | Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. |
| FG001 | Double Dose | Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat (ITT) population included all enrolled participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dose | Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Excreting Resistant Virus | Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1). | ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure. | Posted | Number | percentage of participants | Day 5 |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dose | Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramps | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. "Other" in the category included abdominal pain, breathlessness, thoracic pain and tired. |
| Day 5 |
| Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected | Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category. | Day 5 |
| São Paulo |
| 04025-002 |
| Brazil |
| São Paulo | 05508-000 | Brazil |
| Double Dose |
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
|
|
|
| Secondary | Percentage of Participants With A Reduction in Viral Load | Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load. | ITT population. | Posted | Number | percentage of participants | Baseline, Day 5 |
|
|
|
|
| Secondary | Number of Participants With Various Clinical Signs and Symptoms | Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. "Other" in the category included abdominal pain, breathlessness, thoracic pain and tired. | ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure. | Posted | Number | participants | Day 5 |
|
|
|
|
| Secondary | Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected | Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category. | ITT population. Here "number of participants analyzed" included evaluable participants for the outcome measure. | Posted | Number | participants | Day 5 |
|
|
|
| 0 |
| 19 |
| 8 |
| 19 |
| EG001 | Double Dose | Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days. | 0 | 18 | 7 | 18 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tracheobronchitis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Sore throat |
|
| Shortness of breath |
|
| Diarrhea |
|
| Headache |
|
| Conjunctivitis |
|
| Vomiting |
|
| Other |
|
| Chi-squared |
| 0.284 |
| No |
| Superiority or Other |
| Sore throat: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 1.000 | No | Superiority or Other |
| Shortness of breath: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 1.000 | No | Superiority or Other |
| Diarrhea: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 0.487 | No | Superiority or Other |
| Headache: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 0.593 | No | Superiority or Other |
| Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 1.000 | No | Superiority or Other |
| Vomiting: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 1.000 | No | Superiority or Other |
| Other: statistical difference between 2 groups was based on fisher-exact test. | Fisher Exact | 0.106 | No | Superiority or Other |
| Shortness of breath |
|