InfluenzaPhase 3NCT00949533
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
A Phase 3 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 3 sites in Brazil.
Trial summary
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]… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesBrazil
- Study dates
- Aug 2009to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- positive rapid antigen test for influenza A
- onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours
Who cannot join
- clinical suspicion of infection with a respiratory virus other than influenza
- suspicion of invasive bacterial infection
- evidence of poorly controlled underlying disease
- known immunosuppression
- known allergy to Oseltamivir
- women who are pregnant or planning to get pregnant during the study
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Study site
Curitiba, 80810-040
Study site
São Paulo, 04025-002
Study site
São Paulo, 05508-000
About this study
Official title: A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose
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.
- Conditions
- Influenza
- Being tested
- Oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Tamiflu
Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oseltamivir |
| 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. Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Excreting Resistant Virus
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Measured: Day 5
Secondary outcomes (3)
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.
Measured: Baseline, Day 5
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.
Measured: 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.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949533
- Sponsor's protocol ID
- ML22789
- Status last verified
- Jun 2016
- First submitted
- 15 Jul 2009
- Last updated
- 8 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose
- ClinicalTrials.gov ID
- NCT00949533
- Acronym / sponsor ID
- ML22789
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose | Experimental | Drug: OseltamivirOseltamivir 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 | Drug: OseltamivirOseltamivir 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- positive rapid antigen test for influenza A
- onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours
Key exclusion criteria (6 listed)
- clinical suspicion of infection with a respiratory virus other than influenza
- suspicion of invasive bacterial infection
- evidence of poorly controlled underlying disease
- known immunosuppression
- known allergy to Oseltamivir
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OseltamivirAlso: TamifluStandard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days | Drug | Double Dose, Standard Dose |
Primary outcome
Percentage of Participants Excreting Resistant Virus
Time frame: Day 5
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
3 secondary outcomes
Percentage of Participants With A Reduction in Viral Load
Time frame: Baseline, Day 5
Number of Participants With Various Clinical Signs and Symptoms
Time frame: Day 5
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Time frame: Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Excreting Resistant Virus (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.