A Study of ALS-008176 in Infants Hospitalized With RSV



Status:Completed
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:July 23, 2014
End Date:February 15, 2018

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

A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect
of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial
virus (RSV)


Inclusion Criteria:

- Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the
time of hospital admission, or <28 days of age (neonate cohort only). Note: all
subjects, including neonates, must have been discharged from the hospital after birth
and are now being admitted due to an RSV related illness

Exclusion Criteria:

- Prematurity

- Receiving invasive endotracheal mechanical ventilation

- Poorly functioning gastrointestinal tract

- Anticipated to be discharged from the hospital in <24 hours from the time of
randomization

- Prior exposure to palivizumab
We found this trial at
18
sites
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Canberra, 2606
?
mi
from
Canberra,
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64108
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana
?
mi
from
Shreveport, LA
Click here to add this to my saved trials