InfluenzaPhase 4NCT00412737
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
A Phase 4 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 78 sites in 14 countries.
Trial summary
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). 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?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 78 sitesin 14 countries
- Study dates
- Jan 2007to May 2008
- Phase
- Phase 4
- 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
- Negative rapid diagnostic test for influenza at baseline;
- Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
Who cannot join
- Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
- Influenza vaccination in 6 weeks prior to randomization;
- Positive rapid diagnostic test for influenza;
- Solid organ transplant within 6 months of randomization;
- Antiviral treatment for influenza in 2 weeks prior to randomization.
Trial locations and contacts
78 sites in 14 countries.
78 sites in 14 countries
United States34 sites
Study site
Atlanta, Georgia, 30309
Study site
Augusta, Georgia, 30912
Study site
Birmingham, Alabama, 35233
Study site
Brooklyn Center, Minnesota, 55430
Study site
Buffalo, New York, 14263
Study site
Camden, New Jersey, 08103
Study site
Chapel Hill, North Carolina, 27599-7211
Study site
Charlotte, North Carolina, 28207
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75203
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48201
Study site
Detroit, Michigan, 48202-2689
Study site
Durham, North Carolina, 27705
Study site
Hackensack, New Jersey, 07601
Study site
Hartford, Connecticut, 06106-3316
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77030
Study site
Little Rock, Arkansas, 72202
Study site
Livingston, New Jersey, 07039
Study site
Missoula, Montana, 59802
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10023
Study site
New York, New York, 10032
Study site
Newark, Delaware, 19718
Study site
Newark, New Jersey, 07112
Study site
Oklahoma City, Oklahoma, 73112-44A1
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15213
Study site
St. Petersburg, Florida, 33701
Study site
Stanford, California, 94305
Germany6 sites
Study site
Aachen, 52057
Study site
Berlin, 10098
Study site
Hamburg, 20251
Study site
Heidelberg, 69120
Study site
München, 80336
Study site
München, 81675
Belgium5 sites
Study site
Aalst, 9300
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Edegem, 2650
Study site
Leuven, 3000
Canada5 sites
Study site
Coquitlam, British Columbia, V3K 3P4
Study site
Edmonton, Alberta, T6G 2B7
Study site
London, Ontario, N6A 5A5
Study site
Saskatoon, Saskatchewan, S7M 0Z9
Study site
Winnipeg, Manitoba, R3E 3P4
France5 sites
Study site
Paris, 75019
Study site
Paris, 75475
Study site
Paris, 75743
Study site
Toulouse, 31054
Study site
Tours, 37044
Poland5 sites
Study site
Bialystok, 15-540
Study site
Lodz, 90-153
Study site
Szczecin, 70-111
Study site
Warsaw, 02-006
Study site
Warsaw, 04-730
Hungary3 sites
Study site
Budapest, 1097
Study site
Pécs, 7624
Study site
Szeged, 6720
Israel3 sites
Study site
Jerusalem, 91120
Study site
Petah Tikva, 49100
Study site
Ramat Gan, 52621
Italy3 sites
Study site
Padova, 35128
Study site
Pavia, 27100
Study site
Roma, 00168
United Kingdom2 sites
Study site
Birmingham, B15 2TH
Study site
Edinburgh, EH16 4SA
About this study
Official title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
- Conditions
- Influenza
- Being tested
- Oseltamivir, Placebo
- 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
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
PlaceboDrug
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir | Experimental | Not described Receives: Drug: Oseltamivir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Secondary outcomes (6)
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Measured: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 477 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
- NCT00412737
- Sponsor's protocol ID
- NV20235
- Status last verified
- May 2016
- First submitted
- 15 Dec 2006
- Last updated
- 10 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ison MG, Szakaly P, Shapira MY, Krivan G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.
PubMed 22728756
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT00412737
- Acronym / sponsor ID
- NV20235
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Dec 2006 (estimated)
- Results
- Posted 9 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir | Experimental | Drug: Oseltamivir |
| Placebo | Placebo comparator | Drug: Placebo |
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)
- Negative rapid diagnostic test for influenza at baseline;
- Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
Key exclusion criteria (5 listed)
- Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
- Influenza vaccination in 6 weeks prior to randomization;
- Positive rapid diagnostic test for influenza;
- Solid organ transplant within 6 months of randomization;
- Antiviral treatment for influenza in 2 weeks prior to randomization.
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: TamifluOseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. | Drug | Oseltamivir |
| PlaceboPlacebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. | Drug | Placebo |
Primary outcome
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
6 secondary outcomes
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22728756Ison MG, Szakaly P, Shapira MY, Krivan G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.
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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
78 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 78 sites in 14 countries.
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 5 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Germany, Belgium, Canada, France and 9 more countries. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Sep 2009). 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?
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population (time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412737, which also lists 1 linked publication.
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 10 Jun 2016.