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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01797419




Registration number
NCT01797419
Ethics application status
Date submitted
20/02/2013
Date registered
22/02/2013
Date last updated
28/10/2013

Titles & IDs
Public title
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
Scientific 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
Secondary ID [1] 0 0
GS-US-218-0104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-5806
Treatment: Drugs - Placebo

Experimental: GS-5806 - Single dose, oral liquid, .5 mL/kg

Placebo Comparator: Placebo - Single dose, oral liquid, .5 mL/kg


Treatment: Drugs: GS-5806
Single dose, oral liquid, .5 mL/kg

Treatment: Drugs: Placebo
Single dose, oral liquid, .5 mL/kg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
10 days from subject randomization to study drug
Secondary outcome [1] 0 0
Pharmacokinetics effects of GS-5806
Timepoint [1] 0 0
10 days from subject randomization to study drug

Eligibility
Key inclusion criteria
- <24 months of age

- Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening
Minimum age
1 Hour
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chronic or congenital heart disease

- Required ventilation or admission to any pediatric Intensive Care Unit

- Inadequate organ function

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2013
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Geelong Hospital - Geelong
Recruitment hospital [2] 0 0
Monash Medical Center - Clayton
Recruitment hospital [3] 0 0
Queensland Children's Medical Research Unit - Herston
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Women's and Children's Hospital Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [8] 0 0
Princess Margaret Hospital for Children - Subiaco
Recruitment hospital [9] 0 0
Westmead Children's Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
- North Adelaide
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Randwick
Recruitment postcode(s) [8] 0 0
- Subiaco
Recruitment postcode(s) [9] 0 0
- Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
GS-5806 in hospitalized infants with RSV.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01797419
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Sly, MD
Address 0 0
Queensland Children's Medical Research Unit, Herston, AUS
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01797419