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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02673476




Registration number
NCT02673476
Ethics application status
Date submitted
29/01/2016
Date registered
4/02/2016
Date last updated
25/10/2017

Titles & IDs
Public title
A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus
Scientific title
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus-Related Illness
Secondary ID [1] 0 0
ALS-8176-510
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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALS-008176
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Identical Placebo Comparator

Experimental: ALS-008176 - ALS-008176 tablets


Treatment: Drugs: ALS-008176
ALS-008176 tablets

Treatment: Drugs: Placebo
Identical placebo tablets

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC of RSV RNA - Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.
Timepoint [1] 0 0
From prior to first dose to study day 7
Secondary outcome [1] 0 0
Time from baseline to non-detectability of RSV from nasal swab - Time from baseline to non-detectability of RSV from nasal swab
Timepoint [1] 0 0
From prior first dose to study day 28
Secondary outcome [2] 0 0
Percent of subjects with undetectable RSV by qPCR - Percent of subjects with undetectable RSV by qPCR on Day 3, Day 5, and every other day until 2 days after last dose from nasal swab
Timepoint [2] 0 0
From study day 3, and every two days until study day 7
Secondary outcome [3] 0 0
Peak post-baseline viral load - Peak post-baseline viral load from nasal swab
Timepoint [3] 0 0
From before first dose to study day 28
Secondary outcome [4] 0 0
Rate of decline from baseline in viral load during treatment from nasal swab - Rate of decline from baseline in viral load during treatment from nasal swab
Timepoint [4] 0 0
From before first dose to study day 2
Secondary outcome [5] 0 0
Duration of hospital stay - Duration of hospital stay
Timepoint [5] 0 0
From first dose to study day 28
Secondary outcome [6] 0 0
Safety data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results - Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).
Timepoint [6] 0 0
From screening to study day 28
Secondary outcome [7] 0 0
PK parameters: Cmax - PK parameters in plasma following repeat dose administration: Cmax
Timepoint [7] 0 0
From first dose to study day 28
Secondary outcome [8] 0 0
PK parameters: tmax - PK parameters in plasma following repeat dose administration: tmax
Timepoint [8] 0 0
From first dose to study day 28
Secondary outcome [9] 0 0
PK parameters: AUClast - PK parameters in plasma following repeat dose administration: AUClast
Timepoint [9] 0 0
From first dose to study day 28
Secondary outcome [10] 0 0
PK parameters: t1/2 - PK parameters in plasma following repeat dose administration: t1/2
Timepoint [10] 0 0
From first dose to study day 28
Secondary outcome [11] 0 0
PK parameters: AUC0 tau - PK parameters in plasma following repeat dose administration: AUC0 tau
Timepoint [11] 0 0
From first dose to study day 28

Eligibility
Key inclusion criteria
1. Subject is =50 years of age.

2. Female subjects of non-childbearing potential (i.e., surgically sterilized,
post-menopausal [amenorrhea for 1 year confirmed by negative hormone panel]) who also
have a negative pregnancy test at screening.

3. Male subjects must be either surgically sterilized (e.g., post-vasectomy or
orchiectomy) or willing to adhere to the study's contraceptive requirements. Male
subjects'female partner(s) must be surgically sterilized or post-menopausal
(amenorrhea for 1 year) or their female partner(s) of child-bearing potential must be
willing and able to adhere to the contraceptive requirements.

4. Each subject or their legal guardian must sign an informed consent form (ICF)
indicating that he or she understands the purpose of and procedures required for the
study and is willing to participate in the study before starting any screening
activities.

5. Subject has a positive RT-PCR test result for RSV at the time of screening. NOTE:
Co-infection with other acute viruses or bacteria is permitted.

6. Subject has been, or will be, admitted to the hospital for an acute respiratory
illness with signs and symptoms consistent with a viral infection (e.g., fever, cough,
nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or
wheezing) with onset <7 days from the anticipated time of randomization.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an
estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) <30
mL/min.

2. Subject has presence of any concurrent illness, including laboratory, vital sign, ECG,
or physical exam findings, or medical history that, in the opinion of the
investigator, would place the subject at an unreasonably increased risk as a result of
participation in this study.

3. Subject reports receiving an investigational drug or vaccine within 30 days, or 5
half-lives (whichever is longer) prior to the planned first dose of study drug.

4. Subject has a known history of human immunodeficiency virus (HIV) or chronic, active
hepatitis infection.

5. ALT >3×ULN AND bilirubin >2×ULN (direct >35%) OR ALT>5×ULN

6. Subjects who have been hospitalized for >72 hours at the time of randomization.

7. Subjects anticipated to be hospitalized for <24 hours after randomization.

8. Subjects who are not expected to survive for <48 hours.

9. Recent (<5 half-lives) use, or anticipated use during conduct of the study, of
concomitant medications (prescription and non-prescription) which are inhibitors of
the OAT3 transporter.

10. Treatment of the current illness with drugs specifically targeting the RSV infection
itself (e.g., RSV immunoglobulin, ribavirin, palivizumab). Medications treating the
sequelae of the RSV infection or any concurrent illness are permitted if not otherwise
excluded.

11. Subjects unwilling to undergo regular nasal swab procedures or with any physical
abnormality which limits the ability to collect regular nasal specimens.

12. Subjects that are considered by the investigator to be immunocompromised over the past
12 months, whether due to underlying medical condition or medical therapy.

13. Subjects unable to take medications enterally (e.g., orally or via nasogastric or PEG
tube) or a known gastrointestinal-related condition that may interfere with study drug
absorption.

14. Female subject that is pregnant or breastfeeding

15. In the investigator's opinion, the subject is unwilling or unable to comply with
protocol requirements, instructions, and protocol stated restrictions, and is unlikely
to complete the study as planned.

16. Subject has known or suspected hypersensitivity to the study drug or its excipients
(microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate,
polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide).

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Northmead
Recruitment hospital [2] 0 0
Cairns Hospital - Cairns
Recruitment hospital [3] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
Monash Heal.-Monash Lung&Sleep - Clayton
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Northmead
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore
Country [8] 0 0
Taiwan
State/province [8] 0 0
New Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alios Biopharma Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being to see how effective and safe ALS-008176 is in treating adults in the
hospital with a Respiratory Syncytial Virus-Related Illness.
Trial website
https://clinicaltrials.gov/show/NCT02673476
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Abbie Oey
Address 0 0
Alios Biopharma Inc.
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
Other publications