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Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

NCT03418571 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-07-30

Study results available
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Summary

This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.

Based on the results of the Phase IIb dose-ranging study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study.

Conditions

  • Respiratory Syncytial Virus Lower Respiratory Tract Infection

Interventions

BIOLOGICAL

ALX-0171 1.5 mg/kg

ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.

OTHER

Placebo

Placebo was administered via a single inhalation once daily for 3 consecutive days.

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Ablynx NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
28 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • Japan

Study Locations

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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 NCT03418571 on ClinicalTrials.gov