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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01797419
First received: February 20, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Drug: GS-5806
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 10 days from subject randomization to study drug ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.


Secondary Outcome Measures:
  • Pharmacokinetics effects of GS-5806 [ Time Frame: 10 days from subject randomization to study drug ] [ Designated as safety issue: No ]
    Evaluation of GS-5806 on viral load related and symptom related endpoints.


Enrollment: 0
Study Start Date: May 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797419

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797419     History of Changes
Other Study ID Numbers: GS-US-218-0104
Study First Received: February 20, 2013
Last Updated: October 24, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Gilead Sciences:
Respiratory
Syncytial
Virus
RSV

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 16, 2014