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

October 24, 2013 updated by: Gilead Sciences

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia
        • Monash Medical Center
      • Herston, Australia
        • Queensland Children's Medical Research Unit
      • Hobart, Australia
        • Royal Hobart Hospital
      • North Adelaide, Australia
        • Women's and Children's Hospital Adelaide
      • Parkville, Australia
        • Royal Children's Hospital
      • Randwick, Australia
        • Sydney Children's Hospital
      • Subiaco, Australia
        • Princess Margaret Hospital for Children
      • Westmead, Australia
        • Westmead Children's Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Geelong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GS-5806
Single dose, oral liquid, .5 mL/kg
Drug: GS-5806
Single dose, oral liquid, .5 mL/kg
Placebo Comparator: Placebo
Single dose, oral liquid, .5 mL/kg
Drug: Placebo
Single dose, oral liquid, .5 mL/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 10 days from subject randomization to study drug
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics effects of GS-5806
Time Frame: 10 days from subject randomization to study drug
Evaluation of GS-5806 on viral load related and symptom related endpoints.
10 days from subject randomization to study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Principal Investigator: Peter Sly, MD, Queensland Children's Medical Research Unit, Herston, AUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-218-0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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