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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Bradenton, Florida 34209
861
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Addison, Texas 75001
905
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110
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Athens, Alabama 35611
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Atlanta, Georgia
436
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Austin, Texas
1065
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Avon, Indiana 46123
179
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Baytown, Texas 77521
977
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Bellevue, Nebraska
679
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Berlin, New Jersey
428
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Boynton Beach, Florida
943
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Bozeman, Montana
1464
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Brooklyn, New York 11201
280
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2627 North Hollywood Way
Burbank, California 91505
1974
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Canoga Park, California 91303
1987
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Canton, Massachusetts 02021
636
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Canton, Ohio
103
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Carrollton, Texas 75010
908
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Centennial, Colorado 80249
1157
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Centerville, Ohio 45459
108
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Channelview, Texas
980
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Charleston, South Carolina
525
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Charlotte, North Carolina 28210
348
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3715 Clemmons Road
Clemmons, North Carolina 27012
308
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700 West Ironwood Drive
Coeur d'Alene, Idaho 83814
1749
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529
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1
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Cornelius, North Carolina 28031
331
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Corpus Christi, Texas 78413
1174
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Council Bluffs, Iowa 51503
678
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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
720
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911
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63
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433
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DeLand, Florida 32720
761
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1162
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922
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Diamond Bar, California 91765
1949
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989
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Draper, Utah 84020
1514
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300 South Pierce Street
El Cajon, California 92020
1939
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1922
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279
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Fayetteville, North Carolina 28314
408
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Fort Lauderdale, Florida 33308
970
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938
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16948 East Colony Drive
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114
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Franklin, Tennessee 37064
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Gainesville, Florida 32607
713
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2030
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Greenbrae, California 94904
2109
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321
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Gulf Shores, Alabama 36542
721
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752 Signal Point Road
Guntersville, Alabama 35976
427
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Gurnee, Illinois 60031
305
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Harleysville, Pennsylvania 19438
403
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Hawaiian Gardens, California 90716
1969
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987
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306
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Huntington Beach, California 92647
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669
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208
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1008
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810
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La Crosse, Wisconsin 54601
498
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La Vista, Nebraska 68128
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884
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Lake Worth, Florida 33461
937
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500 Lakewood Center Mall
Lakewood, California 90712
1972
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Lauderdale Lakes, Florida 33319
967
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Lexington, North Carolina 27292
323
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623
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Lomita, California 90171
1982
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1977
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1972
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McAllen, Texas 78503
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885
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798
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994
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989
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18660 Bagley Road
Middleburg Heights, Ohio 44130
115
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Middleton, Wisconsin 53562
399
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335
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Mishawaka, Indiana 46544
201
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Montclair, California 91763
1942
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Mooresville, North Carolina
325
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Morganton, North Carolina 28655
300
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332
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1975
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