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Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Withdrawn
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
GS-5806
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory, Syncytial, Virus, RSV

Eligibility Criteria

1 Hour - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • <24 months of age
  • Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening

Exclusion Criteria:

  • Chronic or congenital heart disease
  • Required ventilation or admission to any pediatric Intensive Care Unit
  • Inadequate organ function

Sites / Locations

  • Geelong Hospital
  • Monash Medical Center
  • Queensland Children's Medical Research Unit
  • Royal Hobart Hospital
  • Women's and Children's Hospital Adelaide
  • Royal Children's Hospital
  • Sydney Children's Hospital
  • Princess Margaret Hospital for Children
  • Westmead Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GS-5806

Placebo

Arm Description

Single dose, oral liquid, .5 mL/kg

Single dose, oral liquid, .5 mL/kg

Outcomes

Primary Outcome Measures

Safety and tolerability
Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.

Secondary Outcome Measures

Pharmacokinetics effects of GS-5806
Evaluation of GS-5806 on viral load related and symptom related endpoints.

Full Information

First Posted
February 20, 2013
Last Updated
October 24, 2013
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01797419
Brief Title
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory, Syncytial, Virus, RSV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GS-5806
Arm Type
Experimental
Arm Description
Single dose, oral liquid, .5 mL/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose, oral liquid, .5 mL/kg
Intervention Type
Drug
Intervention Name(s)
GS-5806
Intervention Description
Single dose, oral liquid, .5 mL/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose, oral liquid, .5 mL/kg
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.
Time Frame
10 days from subject randomization to study drug
Secondary Outcome Measure Information:
Title
Pharmacokinetics effects of GS-5806
Description
Evaluation of GS-5806 on viral load related and symptom related endpoints.
Time Frame
10 days from subject randomization to study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <24 months of age Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening Exclusion Criteria: Chronic or congenital heart disease Required ventilation or admission to any pediatric Intensive Care Unit Inadequate organ function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Sly, MD
Organizational Affiliation
Queensland Children's Medical Research Unit, Herston, AUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Monash Medical Center
City
Clayton
Country
Australia
Facility Name
Queensland Children's Medical Research Unit
City
Herston
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
Country
Australia
Facility Name
Women's and Children's Hospital Adelaide
City
North Adelaide
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
Country
Australia
Facility Name
Sydney Children's Hospital
City
Randwick
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Subiaco
Country
Australia
Facility Name
Westmead Children's Hospital
City
Westmead
Country
Australia

12. IPD Sharing Statement

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Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

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