Respiratory Syncytial Virus InfectionsPhase 1NCT01797419
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
A Phase 1 study testing GS-5806 in people with Respiratory Syncytial Virus Infections, run by Gilead Sciences at 9 sites in Australia.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV. Read more about this study
- Who is it for?
- Ages 1 hour to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- GS-5806
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 9 sitesAustralia
- Study dates
- May 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <24 months of age
- Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening
Who cannot join
- Chronic or congenital heart disease
- Required ventilation or admission to any pediatric Intensive Care Unit
- Inadequate organ function
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Monash Medical Center
Clayton
Geelong Hospital
Geelong, Victoria, 3220
Queensland Children's Medical Research Unit
Herston
Royal Hobart Hospital
Hobart
Women's and Children's Hospital Adelaide
North Adelaide
Royal Children's Hospital
Parkville
Sydney Children's Hospital
Randwick
Princess Margaret Hospital for Children
Subiaco
Westmead Children's Hospital
Westmead
About this study
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
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- GS-5806, Placebo
- Keywords
- Respiratory, Syncytial, Virus, RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5806Drug
Single dose, oral liquid, .5 mL/kg
PlaceboDrug
Single dose, oral liquid, .5 mL/kg
| Study group | Role | What they receive |
|---|---|---|
| GS-5806 | Experimental | Single dose, oral liquid, .5 mL/kg Receives: Drug: GS-5806 |
| Placebo | Placebo comparator | Single dose, oral liquid, .5 mL/kg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.
Measured: 10 days from subject randomization to study drug
Secondary outcomes (1)
Pharmacokinetics effects of GS-5806
Evaluation of GS-5806 on viral load related and symptom related endpoints.
Measured: 10 days from subject randomization to study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Sly, MD, Principal investigator, Queensland Children's Medical Research Unit, Herston, AUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797419
- Sponsor's protocol ID
- GS-US-218-0104
- Status last verified
- Oct 2013
- First submitted
- 20 Feb 2013
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01797419
- Acronym / sponsor ID
- GS-US-218-0104
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory, Syncytial, Virus, RSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS-5806 | Experimental | Drug: GS-5806Single dose, oral liquid, .5 mL/kg |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose, oral liquid, .5 mL/kg |
Who may qualify
- Ages
- 1 hour to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- <24 months of age
- Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening
Key exclusion criteria (3 listed)
- Chronic or congenital heart disease
- Required ventilation or admission to any pediatric Intensive Care Unit
- Inadequate organ function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-5806Single dose, oral liquid, .5 mL/kg | Drug | GS-5806 |
| PlaceboSingle dose, oral liquid, .5 mL/kg | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Pharmacokinetics effects of GS-5806
Time frame: 10 days from subject randomization to study drug
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Sly, MD principal investigator
Queensland Children's Medical Research Unit, Herston, AUS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-5806 in people with Respiratory Syncytial Virus Infections, run by Gilead Sciences at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 10 days from subject randomization to study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.