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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/NCT02202356




Registration number
NCT02202356
Ethics application status
Date submitted
23/07/2014
Date registered
29/07/2014
Date last updated
4/04/2019

Titles & IDs
Public title
A Study of ALS-008176 in Infants Hospitalized With RSV
Scientific title
A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
Secondary ID [1] 0 0
2013-005104-33
Secondary ID [2] 0 0
ALS-8176-503
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 - ALS-008176
Treatment: Drugs - Placebo

Experimental: ALS-008176 Single Dose - Single dose of ALS-008176 administered orally as a suspension

Placebo Comparator: Placebo Single Dose - Single dose of placebo administered orally as a suspension

Experimental: ALS-008176 Multiple Doses - Multiple doses of ALS-008176 administered orally as a suspension

Placebo Comparator: Placebo Multiple Doses - Multiple doses of placebo administered orally as a suspension


Treatment: Drugs: ALS-008176


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

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Baseline through 6 days post-dose
Primary outcome [2] 0 0
Physical Examinations
Timepoint [2] 0 0
Baseline through 6 days post-dose
Primary outcome [3] 0 0
Vital Signs
Timepoint [3] 0 0
Baseline through 6 days post-dose
Primary outcome [4] 0 0
12-Lead ECGs
Timepoint [4] 0 0
Baseline through 6 days post-dose
Primary outcome [5] 0 0
Clinical Laboratory Results
Timepoint [5] 0 0
Baseline through 6 days post-dose
Secondary outcome [1] 0 0
RSV viral RNA concentrations in nasal aspirates
Timepoint [1] 0 0
Baseline through 6 days post-dose
Secondary outcome [2] 0 0
Emergence of resistance
Timepoint [2] 0 0
Baseline through 6 days post-dose
Secondary outcome [3] 0 0
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Timepoint [3] 0 0
Baseline through 6 days post-dose
Secondary outcome [4] 0 0
Pharmacokinetic parameters, including time to maximum concentration and half-life
Timepoint [4] 0 0
Baseline through 6 days post-dose
Secondary outcome [5] 0 0
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Timepoint [5] 0 0
Baseline through 6 days post-dose
Secondary outcome [6] 0 0
Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
Timepoint [6] 0 0
Baseline through 6 days post-dose

Eligibility
Key inclusion criteria
- Male or female infant who is =1.0 to =12.0 months of age (inclusive), defined at the
time of hospital admission, or <28 days of age (neonate cohort only). Note: all
subjects, including neonates, must have been discharged from the hospital after birth
and are now being admitted due to an RSV related illness
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prematurity

- Receiving invasive endotracheal mechanical ventilation

- Poorly functioning gastrointestinal tract

- Anticipated to be discharged from the hospital in <24 hours from the time of
randomization

- Prior exposure to palivizumab

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Monash Medical Center - Melbourne
Recruitment hospital [3] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [4] 0 0
The Royal Children's Hospital Melbourne - Parkville
Recruitment hospital [5] 0 0
Princess Margaret Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- North Adelaide
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Colombia
State/province [19] 0 0
Bogota
Country [20] 0 0
Colombia
State/province [20] 0 0
Medellin
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
Japan
State/province [23] 0 0
Aomori
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Gunma
Country [26] 0 0
Japan
State/province [26] 0 0
Hiroshima
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Ishikawa
Country [29] 0 0
Japan
State/province [29] 0 0
Kagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Okinawa
Country [31] 0 0
Japan
State/province [31] 0 0
Osaka
Country [32] 0 0
Japan
State/province [32] 0 0
Saitama
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Kochi
Country [36] 0 0
New Zealand
State/province [36] 0 0
Christchurch
Country [37] 0 0
New Zealand
State/province [37] 0 0
Hastings
Country [38] 0 0
New Zealand
State/province [38] 0 0
Wellington
Country [39] 0 0
Panama
State/province [39] 0 0
Chiriqui
Country [40] 0 0
Panama
State/province [40] 0 0
Panama City
Country [41] 0 0
Romania
State/province [41] 0 0
Bucharest
Country [42] 0 0
South Africa
State/province [42] 0 0
Cape Town
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
Thailand
State/province [44] 0 0
Bangkok
Country [45] 0 0
Thailand
State/province [45] 0 0
Khon Kaen
Country [46] 0 0
United Kingdom
State/province [46] 0 0
England
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Scotland
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Wales
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Birmingham
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Brighton
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Nottingham
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect
of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial
virus (RSV)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02202356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew McClure, M.D.
Address 0 0
Alios BioPharma
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/NCT02202356