Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection
1 other identifier
interventional
N/A
1 country
9
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2013
Shorter than P25 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 22, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 28, 2013
October 1, 2013
3 months
February 20, 2013
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.
10 days from subject randomization to study drug
Secondary Outcomes (1)
Pharmacokinetics effects of GS-5806
10 days from subject randomization to study drug
Study Arms (2)
GS-5806
EXPERIMENTALSingle dose, oral liquid, .5 mL/kg
Placebo
PLACEBO COMPARATORSingle dose, oral liquid, .5 mL/kg
Interventions
Eligibility Criteria
You may qualify if:
- \<24 months of age
- Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening
You may not qualify if:
- Chronic or congenital heart disease
- Required ventilation or admission to any pediatric Intensive Care Unit
- Inadequate organ function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (9)
Geelong Hospital
Geelong, Victoria, 3220, Australia
Monash Medical Center
Clayton, Australia
Queensland Children's Medical Research Unit
Herston, Australia
Royal Hobart Hospital
Hobart, Australia
Women's and Children's Hospital Adelaide
North Adelaide, Australia
Royal Children's Hospital
Parkville, Australia
Sydney Children's Hospital
Randwick, Australia
Princess Margaret Hospital for Children
Subiaco, Australia
Westmead Children's Hospital
Westmead, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Sly, MD
Queensland Children's Medical Research Unit, Herston, AUS
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2013
First Posted
February 22, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 28, 2013
Record last verified: 2013-10