Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
NCT ID: NCT03468829
Last Updated: 2019-03-11
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-02-28
2020-05-31
Brief Summary
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The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
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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 Dose 1
ALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
ALX-0171 Dose 2
ALX-0171 Dose 2
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
Placebo
Placebo
Oral inhalation of Placebo once daily for a maximum of 14 days
Interventions
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ALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
ALX-0171 Dose 2
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
Placebo
Oral inhalation of Placebo once daily for a maximum of 14 days
Eligibility Criteria
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Inclusion Criteria
2. Subject is clinically diagnosed with RSV infection with new onset or acute worsening
3. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
4. Documented RSV infection in the upper respiratory tract (URT)
5. Subject has:
* Diagnosis of RSV lower respiratory tract (LRT) disease or
* Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI)
Others as defined in the protocol
Exclusion Criteria
2. Subject has clinically significant bacterial, fungal or viral pneumonia
3. Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
4. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.
Others as defined in the protocol
18 Years
75 Years
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
Darlinghurst, , Australia
Investigator site
Westmead, , Australia
Investigator site
Leuven, , Belgium
Investigator site 1
Valencia, , Spain
Investigator site 2
Valencia, , Spain
Countries
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Other Identifiers
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2017-003356-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0171-C204
Identifier Type: -
Identifier Source: org_study_id
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