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

Use our guide to learn which trials are right for you!

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
sites
Nashville, Tennessee
618
mi
from
Nashville, TN
Click here to add this to my saved trials
Addison, Texas 75001
335
mi
from
Addison, TX
Click here to add this to my saved trials
898
mi
from
Akron, OH
Click here to add this to my saved trials
Athens, Alabama 35611
637
mi
from
Athens, AL
Click here to add this to my saved trials
Atlanta, Georgia
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas
517
mi
from
Austin, TX
Click here to add this to my saved trials
Avon, Indiana 46123
630
mi
from
Avon, IN
Click here to add this to my saved trials
Baytown, Texas 77521
577
mi
from
Baytown, TX
Click here to add this to my saved trials
Bellevue, Nebraska
255
mi
from
Bellevue, NE
Click here to add this to my saved trials
Berlin, New Jersey
1237
mi
from
Berlin, NJ
Click here to add this to my saved trials
Birmingham, Alabama
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boynton Beach, Florida
1291
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Bozeman, Montana
872
mi
from
Bozeman, MT
Click here to add this to my saved trials
Bradenton, Florida 34209
1132
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brooklyn, New York 11201
1056
mi
from
Brooklyn, NY
Click here to add this to my saved trials
2627 North Hollywood Way
Burbank, California 91505
1171
mi
from
Burbank, CA
Click here to add this to my saved trials
Canoga Park, California 91303
1184
mi
from
Canoga Park, CA
Click here to add this to my saved trials
Canton, Massachusetts 02021
1439
mi
from
Canton, MA
Click here to add this to my saved trials
Canton, Ohio
902
mi
from
Canton, OH
Click here to add this to my saved trials
Carrollton, Texas 75010
335
mi
from
Carrollton, TX
Click here to add this to my saved trials
Centennial, Colorado 80249
400
mi
from
Centennial, CO
Click here to add this to my saved trials
Centerville, Ohio 45459
918
mi
from
Centerville, OH
Click here to add this to my saved trials
Channelview, Texas
572
mi
from
Channelview, TX
Click here to add this to my saved trials
Charleston, South Carolina
1064
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
957
mi
from
Charlotte, NC
Click here to add this to my saved trials
3715 Clemmons Road
Clemmons, North Carolina 27012
969
mi
from
Clemmons, NC
Click here to add this to my saved trials
700 West Ironwood Drive
Coeur d'Alene, Idaho 83814
1177
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
Columbus, Georgia
811
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio
810
mi
from
Columbus, OH
Click here to add this to my saved trials
Cornelius, North Carolina 28031
952
mi
from
Cornelius, NC
Click here to add this to my saved trials
Corpus Christi, Texas 78413
687
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Council Bluffs, Iowa 51503
264
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
335
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas
348
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio
746
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia
805
mi
from
Decatur, GA
Click here to add this to my saved trials
DeLand, Florida 32720
1124
mi
from
DeLand, FL
Click here to add this to my saved trials
Denver, Colorado
409
mi
from
Denver, CO
Click here to add this to my saved trials
DeSoto, Texas 75115
360
mi
from
DeSoto, TX
Click here to add this to my saved trials
Diamond Bar, California 91765
1145
mi
from
Diamond Bar, CA
Click here to add this to my saved trials
Doral, Florida 33166
1311
mi
from
Doral, FL
Click here to add this to my saved trials
Draper, Utah 84020
775
mi
from
Draper, UT
Click here to add this to my saved trials
300 South Pierce Street
El Cajon, California 92020
1131
mi
from
El Cajon, CA
Click here to add this to my saved trials
Ellensburg, Washington 98926
1317
mi
from
Ellensburg, WA
Click here to add this to my saved trials
Evansville, Indiana
559
mi
from
Evansville, IN
Click here to add this to my saved trials
Fayetteville, North Carolina 28314
1067
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33912
1206
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
Click here to add this to my saved trials
16948 East Colony Drive
Fountain Hills, Arizona 85268
829
mi
from
Fountain Hills, AZ
Click here to add this to my saved trials
Franklin, Indiana 46131
695
mi
from
Franklin, IN
Click here to add this to my saved trials
Franklin, Ohio 45005
739
mi
from
Franklin, OH
Click here to add this to my saved trials
Franklin, Tennessee 37064
618
mi
from
Franklin, TN
Click here to add this to my saved trials
Gainesville, Florida 32607
1049
mi
from
Gainesville, FL
Click here to add this to my saved trials
Garden City, New York 11530
1306
mi
from
Garden City, NY
Click here to add this to my saved trials
Gold River, California 95670
1270
mi
from
Gold River, CA
Click here to add this to my saved trials
Greenbrae, California 94904
1343
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greensboro, North Carolina
1001
mi
from
Greensboro, NC
Click here to add this to my saved trials
Gulf Shores, Alabama 36542
776
mi
from
Gulf Shores, AL
Click here to add this to my saved trials
752 Signal Point Road
Guntersville, Alabama 35976
685
mi
from
Guntersville, AL
Click here to add this to my saved trials
1800 Nations Drive
Gurnee, Illinois 60031
612
mi
from
Gurnee, IL
Click here to add this to my saved trials
Harleysville, Pennsylvania 19438
1213
mi
from
Harleysville, PA
Click here to add this to my saved trials
Hawaiian Gardens, California 90716
1164
mi
from
Hawaiian Gardens, CA
Click here to add this to my saved trials
Hialeah, Florida
1313
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hickory, North Carolina 28601
921
mi
from
Hickory, NC
Click here to add this to my saved trials
Houston, Texas
569
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
1164
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Huntsville, Alabama 35801
659
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jackson, Tennessee 38305
520
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida
1055
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johnston, Rhode Island
?
mi
from
Johnston, RI
Click here to add this to my saved trials
Kalamazoo, Michigan
718
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Katy, Texas 77450
562
mi
from
Katy, TX
Click here to add this to my saved trials
Kissimmee, Florida 34741
1149
mi
from
Kissimmee, FL
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
541
mi
from
La Crosse, WI
Click here to add this to my saved trials
La Vista, Nebraska 68128
255
mi
from
La Vista, NE
Click here to add this to my saved trials
Lake Charles, Louisiana
582
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lake Worth, Florida 33461
1288
mi
from
Lake Worth, FL
Click here to add this to my saved trials
500 Lakewood Center Mall
Lakewood, California 90712
1167
mi
from
Lakewood, CA
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
1302
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lexington, North Carolina 27292
979
mi
from
Lexington, NC
Click here to add this to my saved trials
Little Rock, Arkansas
371
mi
from
Little Rock, AR
Click here to add this to my saved trials
Lomita, California 90171
1178
mi
from
Lomita, CA
Click here to add this to my saved trials
Long Beach, California
1172
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin 53717
575
mi
from
Madison, WI
Click here to add this to my saved trials
McAllen, Texas 78503
798
mi
from
McAllen, TX
Click here to add this to my saved trials
McKinney, Texas 75069
321
mi
from
McKinney, TX
Click here to add this to my saved trials
Metairie, Louisiana 70006
693
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida
1322
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Springs, Florida
1314
mi
from
Miami Springs, FL
Click here to add this to my saved trials
18660 Bagley Road
Middleburg Heights, Ohio 44130
886
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
8383 Greenway Boulevard
Middleton, Wisconsin 53562
570
mi
from
Middleton, WI
Click here to add this to my saved trials
Midlothian, Virginia 23114
1101
mi
from
Midlothian, VA
Click here to add this to my saved trials
Mishawaka, Indiana 46544
675
mi
from
Mishawaka, IN
Click here to add this to my saved trials
Montclair, California 91763
1137
mi
from
Montclair, CA
Click here to add this to my saved trials
Mooresville, North Carolina
953
mi
from
Mooresville, NC
Click here to add this to my saved trials
Morganton, North Carolina 28655
902
mi
from
Morganton, NC
Click here to add this to my saved trials
New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
Norco, California 92860
1133
mi
from
Norco, CA
Click here to add this to my saved trials
North Hollywood, California
1173
mi
from
North Hollywood, CA
Click here to add this to my saved trials