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 |
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)
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
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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University of Utah Research is a major component in the life of the U benefiting...
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Long Beach, California 90806
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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