Status:
COMPLETED
A Study of ALS-008176 in Infants Hospitalized With RSV
Lead Sponsor:
Alios Biopharma Inc.
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE1
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2018
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT02202356
Start Date
July 23 2014
End Date
February 15 2018
Last Update
February 3 2025
Active Locations (77)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
3
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
Long Beach, California, United States, 90806
4
Children's Hospital of Orange County
Orange, California, United States, 92868