Safety Study of GS-5806 to Treat Respiratory Syncytial Vi... | NCT01797419

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

NCT01797419

Sponsor

Gilead Sciences

Status

Withdrawn

Last Update Posted

Oct 28, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Interventions

GS-5806
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Feb 20, 2013

First Submission Date that Met QC Criteria

Feb 20, 2013

First Posted Date

Feb 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2013

Last Update Posted Date

Oct 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GS-5806	Experimental	Single dose, oral liquid, .5 mL/kg	Drug: GS-5806
Placebo	Placebo Comparator	Single dose, oral liquid, .5 mL/kg	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GS-5806	Drug	Single dose, oral liquid, .5 mL/kg	GS-5806
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Sly, MD	Queensland Children's Medical Research Unit, Herston, AUS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geelong Hospital		Geelong	Victoria	3220	Australia
Monash Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D018357	Respiratory Syncytial Virus Infections
D014777	Virus Diseases

Ancestor Terms

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000591241	presatovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided