NCT03468829

Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection

A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 hematopoietic stem cell transplantation (HSCT). 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.

Conditions

• Respiratory Syncytial Virus Lower Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0171 Dose 1	Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
BIOLOGICAL	ALX-0171 Dose 2	Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
BIOLOGICAL	Placebo	Oral inhalation of Placebo once daily for a maximum of 14 days

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-03-19
• Last updated: 2019-03-11

Locations

5 sites across 3 countries: Australia, Belgium, Spain

Regulatory

• FDA-regulated drug study