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

NCT ID: NCT01797419

Last Updated: 2013-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Keywords

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Respiratory Syncytial Virus RSV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GS-5806

Single dose, oral liquid, .5 mL/kg

Group Type EXPERIMENTAL

GS-5806

Intervention Type DRUG

Single dose, oral liquid, .5 mL/kg

Placebo

Single dose, oral liquid, .5 mL/kg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose, oral liquid, .5 mL/kg

Interventions

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GS-5806

Single dose, oral liquid, .5 mL/kg

Intervention Type DRUG

Placebo

Single dose, oral liquid, .5 mL/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Sly, MD

Role: PRINCIPAL_INVESTIGATOR

Queensland Children's Medical Research Unit, Herston, AUS

Locations

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Geelong Hospital

Geelong, Victoria, Australia

Site Status

Monash Medical Center

Clayton, , Australia

Site Status

Queensland Children's Medical Research Unit

Herston, , Australia

Site Status

Royal Hobart Hospital

Hobart, , Australia

Site Status

Women's and Children's Hospital Adelaide

North Adelaide, , Australia

Site Status

Royal Children's Hospital

Parkville, , Australia

Site Status

Sydney Children's Hospital

Randwick, , Australia

Site Status

Princess Margaret Hospital for Children

Subiaco, , Australia

Site Status

Westmead Children's Hospital

Westmead, , Australia

Site Status

Countries

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Australia

Other Identifiers

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GS-US-218-0104

Identifier Type: -

Identifier Source: org_study_id