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Trial record 2 of 7 for:    GS-5806

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01797419
Recruitment Status : Withdrawn
First Posted : February 22, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: GS-5806 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797419


Locations
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Australia, Victoria
Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia
Monash Medical Center
Clayton, Australia
Queensland Children's Medical Research Unit
Herston, Australia
Royal Hobart Hospital
Hobart, Australia
Women's and Children's Hospital Adelaide
North Adelaide, 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
Sponsors and Collaborators
Gilead Sciences
Investigators
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Principal Investigator: Peter Sly, MD Queensland Children's Medical Research Unit, Herston, AUS

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797419    
Other Study ID Numbers: GS-US-218-0104
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013
Keywords provided by Gilead Sciences:
Respiratory
Syncytial
Virus
RSV
Additional relevant MeSH terms:
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Infection
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections