drugset / Trial / NCT03418571
Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
RandomizedSequentialQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2018-10-24
- Completion
- 2018-10-24
Outcome
Outcome not reported
Stopped: “The Sponsor decided to discontinue ALX-0171 development (due to insufficient evidence of efficacy). As a result, the ALX0171-C203 study was early terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALX-0171 | Protein / enzyme biologic | 1.5 mg/kg | Inhaled |