Status:
COMPLETED
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
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Respiratory Syncytial Virus Infection
Eligibility:
All Genders
28-23 years
Phase:
PHASE1
PHASE2
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 pharmacodynam...
Eligibility Criteria
Inclusion
- Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
- Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
- Subject has a positive RSV diagnostic test
- Others as defined in the protocol
Exclusion
- Subject has history of wheezing
- Subject is known to have significant comorbidities
- Subject is known to be immunocompromised
- Subject is suspected of having a clinically relevant infection other than RSV
- Others as defined in the protocol
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02309320
Start Date
December 1 2014
End Date
February 1 2016
Last Update
January 10 2019
Active Locations (59)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigator Site 4
Brisbane, Australia
2
Investigator Site 2
Randwick, Australia, 2031
3
Investigator Site 3
Tasmania, Australia
4
Investigator Site 1
Westmead, Australia, 2145