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

Phase 1

Withdrawn

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: GS-5806; Drug: Placebo

• Registration Number: NCT01797419
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS-5806	GS-5806	Single dose, oral liquid, .5 mL/kg
Placebo	Placebo	Single dose, oral liquid, .5 mL/kg

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	10 days from subject randomization to study drug	Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics effects of GS-5806	10 days from subject randomization to study drug	Evaluation of GS-5806 on viral load related and symptom related endpoints.

Trial Locations

Locations (9)

Geelong Hospital; 🇦🇺 Geelong, Victoria, Australia

Monash Medical Center; 🇦🇺 Clayton, Australia

Queensland Children's Medical Research Unit; 🇦🇺 Herston, Australia

Women's and Children's Hospital Adelaide; 🇦🇺 North Adelaide, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, 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