Respiratory Syncytial Virus Lower Respiratory Tract Infection Clinical Trial
Official title:
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
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.
This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter
dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3
dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part
(Cohort 4).
An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide
recommendations on proceeding to the next safety cohort and on which dose levels could be
taken forward in the parallel part.
Three dose levels of ALX-0171 were evaluated:
- Dose 1: target dose of 3.0 mg/kg
- Dose 2: target dose of 6.0 mg/kg
- Dose 3: target dose of 9.0 mg/kg
The study drug was administered by inhalation once daily for 3 consecutive days along with
standard of care treatment, which was determined by the Investigator (or his/her designee)
according to institutional practice.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03418571 -
Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
|
Phase 2 | |
| Withdrawn |
NCT03468829 -
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
|
Phase 2 |