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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/NCT02309320




Registration number
NCT02309320
Ethics application status
Date submitted
27/11/2014
Date registered
5/12/2014
Date last updated
10/01/2019

Titles & IDs
Public title
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
Scientific title
A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.
Secondary ID [1] 0 0
2014-002841-23
Secondary ID [2] 0 0
ALX0171-C104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 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
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ALX-0171
Other interventions - Placebo

Experimental: ALX-0171 - Inhalation of ALX-0171 during 3 consecutive days

Placebo Comparator: Placebo - Inhalation of Placebo during 3 consecutive days


Other interventions: ALX-0171


Other interventions: Placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
Timepoint [1] 0 0
1 day before first dose to 14 days after first dose
Secondary outcome [1] 0 0
Clinical activity as measured by the evaluation of the clinical response of the subjects
Timepoint [1] 0 0
1 day before first dose to 14 days after first dose
Secondary outcome [2] 0 0
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Timepoint [2] 0 0
Day 3
Secondary outcome [3] 0 0
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
Timepoint [3] 0 0
1 day before first dose to 14 days after first dose
Secondary outcome [4] 0 0
Immunogenicity as measured by the concentration of anti-drug antibodies in serum
Timepoint [4] 0 0
1 day before first dose to 14 days after first dose

Eligibility
Key inclusion criteria
1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV
LRTI (Lower Respiratory Tract Infection)

2. Subject has appearance of upper or lower respiratory tract infection symptoms that are
likely related to RSV

3. Subject has a positive RSV diagnostic test

4. Others as defined in the protocol
Minimum age
28 Days
Maximum age
23 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has history of wheezing

2. Subject is known to have significant comorbidities

3. Subject is known to be immunocompromised

4. Subject is suspected of having a clinically relevant infection other than RSV

5. Others as defined in the protocol

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/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
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigator Site 4 - Brisbane
Recruitment hospital [2] 0 0
Investigator Site 2 - Randwick
Recruitment hospital [3] 0 0
Investigator Site 3 - Tasmania
Recruitment hospital [4] 0 0
Investigator Site 1 - Westmead
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
- Tasmania
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Kozloduy
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Pleven
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Ruse
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sevlievo
Country [9] 0 0
Estonia
State/province [9] 0 0
Tartu
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Hungary
State/province [11] 0 0
Szeged
Country [12] 0 0
Israel
State/province [12] 0 0
Beer Sheva
Country [13] 0 0
Israel
State/province [13] 0 0
Haifa
Country [14] 0 0
Israel
State/province [14] 0 0
Petah-Tikva
Country [15] 0 0
Latvia
State/province [15] 0 0
Daugavpils
Country [16] 0 0
Latvia
State/province [16] 0 0
Riga
Country [17] 0 0
Latvia
State/province [17] 0 0
Valmiera
Country [18] 0 0
Malaysia
State/province [18] 0 0
Ipoh
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuala Lumpur
Country [20] 0 0
Malaysia
State/province [20] 0 0
Negeri Sembilan
Country [21] 0 0
Malaysia
State/province [21] 0 0
Pulau Pinang
Country [22] 0 0
Philippines
State/province [22] 0 0
Manila
Country [23] 0 0
Philippines
State/province [23] 0 0
Muntinlupa
Country [24] 0 0
Philippines
State/province [24] 0 0
Quezon City
Country [25] 0 0
Poland
State/province [25] 0 0
Bydgoszcz
Country [26] 0 0
Poland
State/province [26] 0 0
Lodz
Country [27] 0 0
Poland
State/province [27] 0 0
Trzebnica
Country [28] 0 0
Slovakia
State/province [28] 0 0
Banska Bystrica
Country [29] 0 0
Slovakia
State/province [29] 0 0
Bratislava
Country [30] 0 0
Slovakia
State/province [30] 0 0
Kosice
Country [31] 0 0
Slovakia
State/province [31] 0 0
Levice
Country [32] 0 0
Slovakia
State/province [32] 0 0
Liptovsky Mikulas
Country [33] 0 0
Slovakia
State/province [33] 0 0
Martin
Country [34] 0 0
Slovakia
State/province [34] 0 0
Poprad
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Girona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Malaga
Country [39] 0 0
Spain
State/province [39] 0 0
Murcia
Country [40] 0 0
Spain
State/province [40] 0 0
Santiago de Compostela
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Thailand
State/province [42] 0 0
Chiang Mai
Country [43] 0 0
Thailand
State/province [43] 0 0
Khon Kaen
Country [44] 0 0
United Kingdom
State/province [44] 0 0
City Of Edinburgh
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Kent
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Liverpool
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Nottingham
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Oxford
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ablynx, a Sanofi company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the
pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02309320
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ablynx Clinical Department
Address 0 0
Ablynx, a Sanofi company
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