At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 180 enrolled
Drug / intervention
ALX-0171 3.0 mg/kg +3 morebiological
Likely dose
ALX-0171 3.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
In Brief
A Phase 2 clinical trial evaluating ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, and 2 other interventions for Respiratory Syncytial Virus Lower Respiratory Tract Infection. Completed, enrolled 180 participants across 74 sites in 17 countries.
Detailed Summary
The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Chile, Colombia, Croatia, Czechia, Estonia, Germany, Hungary, Israel, Latvia, Malaysia, Philippines, Poland, Slovakia, Spain, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedDec 1, 2016
Enrollment StartJan 11, 2017
Primary CompletionMay 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago
Interventions
ALX-0171 3.0 mg/kgbiological
ALX-0171 6.0 mg/kgbiological
ALX-0171 9.0 mg/kgbiological
Placeboother