Status:
WITHDRAWN
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hemat...
Eligibility Criteria
Inclusion
- Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
- Subject is clinically diagnosed with RSV infection with new onset or acute worsening
- Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
- Documented RSV infection in the upper respiratory tract (URT)
- 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
- Subject has clinically significant bacteremia or fungemia within 7 days of screening
- Subject has clinically significant bacterial, fungal or viral pneumonia
- Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03468829
Start Date
February 1 2019
End Date
May 1 2020
Last Update
March 11 2019
Active Locations (5)
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1
Investigator site
Darlinghurst, Australia
2
Investigator site
Westmead, Australia
3
Investigator site
Leuven, Belgium
4
Investigator site 1
Valencia, Spain