A Study of ALS-008176 in Infants Hospitalized With RSV

Completed · Phase 1 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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)

Key facts

Study ID

NCT02202356

Run by

Alios Biopharma Inc.

People needed

183

Starts

2014-07-23

Expected to finish

2018-02-15

Last updated by the study team

2025-02-03

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach — Long Beach, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• The University of California at San Diego — San Diego, California, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Children's Mercy — Kansas City, Missouri, United States
• University of Rochester — Rochester, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital/University of Tennessee — Memphis, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Texas Children's Hospital/Baylor College of Medicine — Houston, Texas, United States
• The University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Canberra Hospital — Canberra, Australia
• Monash Medical Center — Melbourne, Australia
• Women's and Children's Hospital — North Adelaide, Australia
• The Royal Children's Hospital Melbourne — Parkville, Australia
• Princess Margaret Hospital — Perth, Australia
• The Children's Hospital Research Institute of Manitoba — Winnipeg, Manitoba, Canada
• Canadian Centre for Vaccinology IWK Health Centre — Halifax, Nova Scotia, Canada
• McMaster Children's Hospital — Hamilton, Ontario, Canada
• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.