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

NCT03468829 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Ablynx Clinical Department · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468829 on ClinicalTrials.gov