Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - Any
Updated:5/5/2018
Start Date:December 1, 2016
End Date:April 20, 2018

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A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications

The primary objective of this study is to evaluate the efficacy of a single, oral dose of
Baloxavir Marboxil compared with placebo by measuring the time to improvement of influenza
symptoms in patients with influenza presenting within 48 hours of symptom onset.


Inclusion Criteria:

1. Patients or their legal guardians who provide written informed consent to participate
in the study on a voluntary basis. For adolescent patients, informed consent/assent of
voluntary participation should be obtained in accordance with local requirements.

2. Male or female patients ≥ 12 years at the time of signing the informed consent/assent
form.

3. Patients with a diagnosis of influenza confirmed by all of the following:

1. Fever ≥ 38ºC (axillary) during the predose examinations or within the 4 hours
prior if antipyretics were taken

2. A positive rapid influenza diagnostic test (RIDT) result OR A patient with a
negative RIDT may be enrolled if the patient reports contact with a known case of
influenza within the prior 7 days and all other inclusion criteria are met.

3. At least 1 each of the following general and respiratory symptoms associated with
influenza is present with a severity of moderate or greater:

i. General symptoms (headache, feverishness or chills, muscle or joint pain, or
fatigue) ii. Respiratory symptoms (cough, sore throat, or nasal congestion)

4. The time interval between the onset of symptoms and the predose examinations is 48
hours or less. The onset of symptoms is defined as either:

1. Time of the first increase in body temperature (an increase of at least 1ºC from
normal body temperature)

2. Time when the patient experiences at least 1 new general or respiratory symptom

5. If a women of childbearing potential, agrees to use a highly effective method of
contraception for 3 months after the first dose of study drug

6. Patients will be considered at high risk* of influenza complications due to the
presence of at least 1 of the following inclusion criteria:

1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or
cystic fibrosis)

2. Endocrine disorders (including diabetes mellitus)

3. Residents of long-term care facilities (eg, nursing homes)

4. Compromised immune system (including patients receiving corticosteroids not
exceeding 20 mg of prednisolone or equivalent, and patients being treated for
human immunodeficiency virus [HIV] infection with a CD4 count > 350 cells/mm³
within the last 6 months)

5. Neurological and neurodevelopmental disorders (including disorders of the brain,
spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure
disorders], stroke, muscular dystrophy, or spinal cord injury)

6. Heart disease (such as congenital heart disease, congestive heart failure, or
coronary artery disease), excluding hypertension without any other heart-related
symptoms

7. Adults aged ≥ 65 years

8. American Indians and Alaskan Natives

9. Blood disorders (such as sickle cell disease)

10. Metabolic disorders (such as inherited metabolic disorders and mitochondrial
disorders)

11. Morbid obesity (body mass index ≥ 40 kg/m²)

12. Women who are within 2 weeks postpartum and are not breastfeeding

Exclusion Criteria:

1. Patients with severe influenza virus infection requiring inpatient treatment.

2. Patients with known allergy to oseltamivir (Tamiflu®).

3. Patients unable to swallow tablets or capsules.

4. Patients who have previously received Baloxavir Marboxil.

5. Patients weighing ≤ 40 kg.

6. Patients who have been exposed to an investigational drug within 30 days prior to the
predose examinations.

7. Women who are pregnant, breastfeeding, or have a positive pregnancy test at the
predose examinations. The following female patients who have documentation of either a
or b below do not need to undergo a pregnancy test at the predose examinations:

1. Postmenopausal women (defined as cessation of regular menstrual periods for 2
years or more and confirmed by a follicle-stimulating hormone test)

2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or
tubal ligation

8. Patients with concurrent infections at the predose examinations requiring systemic
antimicrobial therapy.

9. Patients with liver disease associated with hepatic impairment.

10. Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).

11. Patients with untreated HIV infection or treated HIV infection with a CD4 count below
350 cells/mm3 in the last 6 months.

12. Patients with immunosuppression following organ or bone marrow transplants.

13. Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic
corticosteroids.

14. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir,
rimantadine, umifenovir or amantadine within 30 days prior to the predose
examinations.

15. Patients who have received an investigational monoclonal antibody for a viral disease
in the last year.

16. Patients with known creatinine clearance ≤ 60 mL/min.

17. Patients who, in the opinion of the investigator, would be unlikely to comply with
required study visits, self-assessments, and interventions
We found this trial at
152
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Kissimmee, Florida 34741
2556
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Addison, Texas 75001
1670
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2041
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Akron, OH
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Athens, Alabama 35611
2017
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Atlanta, Georgia
2178
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Austin, Texas
1770
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Avon, Indiana 46123
1857
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Baytown, Texas 77521
1907
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Bellevue, Nebraska
1372
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Berlin, New Jersey
2389
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Birmingham, Alabama
2079
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Boynton Beach, Florida
2699
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Bozeman, Montana
552
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Bradenton, Florida 34209
2543
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Brooklyn, New York 11201
2129
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2627 North Hollywood Way
Burbank, California 91505
950
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Canoga Park, California 91303
948
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Canton, Massachusetts 02021
2487
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Canton, Ohio
2057
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Carrollton, Texas 75010
1668
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Centennial, Colorado 80249
1032
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Centerville, Ohio 45459
2102
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Channelview, Texas
1899
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Charleston, South Carolina
2423
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Charlotte, North Carolina 28210
2281
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3715 Clemmons Road
Clemmons, North Carolina 27012
2271
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700 West Ironwood Drive
Coeur d'Alene, Idaho 83814
258
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Coeur d'Alene, ID
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Columbus, Georgia
2207
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Columbus, Ohio
2008
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Cornelius, North Carolina 28031
2270
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Corpus Christi, Texas 78413
1916
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Council Bluffs, Iowa 51503
1370
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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
1303
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Dallas, Texas
1681
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Dayton, Ohio
1959
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Decatur, Georgia
2182
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DeLand, Florida 32720
2527
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Denver, Colorado
1020
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DeSoto, Texas 75115
1687
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Diamond Bar, California 91765
968
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Doral, Florida 33166
2722
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Draper, Utah 84020
714
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300 South Pierce Street
El Cajon, California 92020
1063
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Ellensburg, Washington 98926
94
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Evansville, Indiana
1865
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Fayetteville, North Carolina 28314
2379
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Fort Lauderdale, Florida 33308
2717
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Fort Myers, Florida 33912
2618
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Fort Worth, Texas 76104
1662
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16948 East Colony Drive
Fountain Hills, Arizona 85268
1116
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Franklin, Indiana 46131
1906
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Franklin, Ohio 45005
1961
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Franklin, Tennessee 37064
1976
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Gainesville, Florida 32607
2453
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Garden City, New York 11530
2418
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Gold River, California 95670
624
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Greenbrae, California 94904
669
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Greensboro, North Carolina
2297
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Gulf Shores, Alabama 36542
2187
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752 Signal Point Road
Guntersville, Alabama 35976
2068
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1800 Nations Drive
Gurnee, Illinois 60031
1704
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Harleysville, Pennsylvania 19438
2352
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Hawaiian Gardens, California 90716
979
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Hialeah, Florida
2724
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Hickory, North Carolina 28601
2238
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Houston, Texas
1890
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Huntington Beach, California 92647
991
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Huntsville, Alabama 35801
2038
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Jackson, Tennessee 38305
1900
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Jacksonville, Florida
2452
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Johnston, Rhode Island
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Kalamazoo, Michigan
1816
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Katy, Texas 77450
1871
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La Crosse, Wisconsin 54601
1512
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La Vista, Nebraska 68128
1365
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Lake Charles, Louisiana
1954
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Lake Worth, Florida 33461
2697
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500 Lakewood Center Mall
Lakewood, California 90712
977
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Lauderdale Lakes, Florida 33319
2712
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Lexington, North Carolina 27292
2285
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Little Rock, Arkansas
1782
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Lomita, California 90171
978
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Long Beach, California
981
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Los Angeles, California
962
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Madison, Wisconsin 53717
1617
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McAllen, Texas 78503
1974
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McKinney, Texas 75069
1668
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Metairie, Louisiana 70006
2094
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Miami, Florida
2732
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Miami Springs, Florida
2725
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18660 Bagley Road
Middleburg Heights, Ohio 44130
2018
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8383 Greenway Boulevard
Middleton, Wisconsin 53562
1611
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Midlothian, Virginia 23114
2343
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Mishawaka, Indiana 46544
1808
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Montclair, California 91763
967
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Mooresville, North Carolina
2268
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Morganton, North Carolina 28655
2222
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Nashville, Tennessee
1970
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New Orleans, Louisiana 70112
2099
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Norco, California 92860
978
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North Hollywood, California
951
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