Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22728756 | Derived | 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. |
Not provided
Not provided
One participant was randomized to placebo group but received oseltamivir for the first 9 weeks of the study. This participant was included in the placebo group in the Intention-to-treat (ITT) analysis population, but in the oseltamivir group in the safety analysis population.
Out of total 477 participants who were randomized to receive study treatments, 2 participants were not included in the study population due to lack of efficacy data. Thus, results are reported only for 475 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. |
| FG001 | Oseltamivir | Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. |
|
| 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. | 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. | 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. | 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. | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Stanford | California | 94305 | United States |
| Denver | Colorado | 80262 | United States |
| Hartford | Connecticut | 06106-3316 | United States |
| Newark | Delaware | 19718 | United States |
| St. Petersburg | Florida | 33701 | United States |
| Atlanta | Georgia | 30309 | United States |
| Augusta | Georgia | 30912 | United States |
| Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Detroit | Michigan | 48201 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Brooklyn Center | Minnesota | 55430 | United States |
| Missoula | Montana | 59802 | United States |
| Camden | New Jersey | 08103 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Livingston | New Jersey | 07039 | United States |
| Newark | New Jersey | 07112 | United States |
| Buffalo | New York | 14263 | United States |
| New York | New York | 10023 | United States |
| New York | New York | 10032 | United States |
| Chapel Hill | North Carolina | 27599-7211 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Durham | North Carolina | 27705 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Cleveland | Ohio | 44195 | United States |
| Oklahoma City | Oklahoma | 73112-44A1 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Dallas | Texas | 75203 | United States |
| Houston | Texas | 77030 | United States |
| Aalst | 9300 | Belgium |
| Brussels | 1090 | Belgium |
| Brussels | 1200 | Belgium |
| Edegem | 2650 | Belgium |
| Leuven | 3000 | Belgium |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Coquitlam | British Columbia | V3K 3P4 | Canada |
| Winnipeg | Manitoba | R3E 3P4 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Saskatoon | Saskatchewan | S7M 0Z9 | Canada |
| Brno | 639 00 | Czechia |
| Tallinn | 10617 | Estonia |
| Tartu | 51014 | Estonia |
| Paris | 75019 | France |
| Paris | 75475 | France |
| Paris | 75743 | France |
| Toulouse | 31054 | France |
| Tours | 37044 | France |
| Aachen | 52057 | Germany |
| Berlin | 10098 | Germany |
| Hamburg | 20251 | Germany |
| Heidelberg | 69120 | Germany |
| München | 80336 | Germany |
| München | 81675 | Germany |
| Budapest | 1097 | Hungary |
| Pécs | 7624 | Hungary |
| Szeged | 6720 | Hungary |
| Jerusalem | 91120 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Padova | 35128 | Italy |
| Pavia | 27100 | Italy |
| Roma | 00168 | Italy |
| Kaunas | 50009 | Lithuania |
| Vilnius | 08661 | Lithuania |
| Bialystok | 15-540 | Poland |
| Lodz | 90-153 | Poland |
| Szczecin | 70-111 | Poland |
| Warsaw | 02-006 | Poland |
| Warsaw | 04-730 | Poland |
| Madrid | 28006 | Spain |
| Madrid | 28040 | Spain |
| Birmingham | B15 2TH | United Kingdom |
| Edinburgh | EH16 4SA | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. Participants were analyzed as per actual treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. |
| BG001 | Oseltamivir | Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | 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. | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITTNAB population. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITTNAB population. | Posted | Number | participants | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |
|
|
From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. | 23 | 237 | 40 | 237 | ||
| EG001 | Oseltamivir | Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. | 18 | 238 | 42 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
There were no overall limitations and caveats.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Male |
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|