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
NCT ID: NCT02309320
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2014-12-31
2016-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALX-0171
Inhalation of ALX-0171 during 3 consecutive days
ALX-0171
Placebo
Inhalation of Placebo during 3 consecutive days
Placebo
Interventions
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ALX-0171
Placebo
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
28 Days
23 Months
ALL
No
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Ablynx Clinical Department
Role: STUDY_DIRECTOR
Ablynx, a Sanofi company
Locations
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Investigator Site 4
Brisbane, , Australia
Investigator Site 2
Randwick, , Australia
Investigator Site 3
Tasmania, , Australia
Investigator Site 1
Westmead, , Australia
Investigator Site 1
Antwerp, , Belgium
Investigator Site 6
Antwerp, , Belgium
Investigator Site 4
Brussels, , Belgium
Investigator Site 5
Brussels, , Belgium
Investigator Site 2
Ghent, , Belgium
Investigator Site 3
Leuven, , Belgium
Investigator Site 4
Kozloduy, , Bulgaria
Investigator Site 1
Pleven, , Bulgaria
Investigator Site 2
Rousse, , Bulgaria
Investigator Site 3
Sevlievo, , Bulgaria
Investigator Site
Tartu, , Estonia
Investigator Site 1
Budapest, , Hungary
Investigators Site 3
Budapest, , Hungary
Investigator Site 4
Budapest, , Hungary
Investigator Site 5
Budapest, , Hungary
Investigator Site 2
Szeged, , Hungary
Investigator Site 3
Beersheba, , Israel
Investigator Site 2
Haifa, , Israel
Investigator Site 1
Petah Tikva, , Israel
Investigator Site 3
Daugavpils, , Latvia
Investigator Site 2
Riga, , Latvia
Investigator Site 1
Valmiera, , Latvia
Investigator Site 2
Ipoh, , Malaysia
Investigator Site 1
Kuala Lumpur, , Malaysia
Investigator Site 3
Negeri Sembilan, , Malaysia
Investigator Site 4
Pulau Pinang, , Malaysia
Investigator Site
City of Muntinlupa, , Philippines
Investigator Site
Manila, , Philippines
Investigator Site
Quezon City, , Philippines
Investigator Site 3
Bydgoszcz, , Poland
Investigator Site 2
Lodz, , Poland
Investigator Site 1
Trzebnica, , Poland
Investigator Site 5
Banská Bystrica, , Slovakia
Investigator Site 3
Bratislava, , Slovakia
Investigator Site 2
Košice, , Slovakia
Investigator Site 6
Levice, , Slovakia
Investigator Site 7
Liptovský Mikuláš, , Slovakia
Investigator Site 1
Martin, , Slovakia
Investigator Site 4
Poprad, , Slovakia
Investigator Site 5
Barcelona, , Spain
Investigator Site 2
Barcelona, , Spain
Investigator Site 4
Girona, , Spain
Investigator Site 3
Madrid, , Spain
Investigator Site 7
Málaga, , Spain
Investigator Site 6
Murcia, , Spain
Investigator Site 1
Santiago de Compostela, , Spain
Investigator Site 8
Seville, , Spain
Investigator Site 2
Chiang Mai, , Thailand
Investigator Site
Khon Kaen, , Thailand
Investigator Site 2
City of Edinburgh, , United Kingdom
Investigator Site 4
Kent, , United Kingdom
Investigator Site 5
Liverpool, , United Kingdom
Investigator Site 6
Nottingham, , United Kingdom
Investigator Site 1
Oxford, , United Kingdom
Investigator Site 3
Tooting, , United Kingdom
Countries
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Other Identifiers
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2014-002841-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0171-C104
Identifier Type: -
Identifier Source: org_study_id
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