A Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection

Summary

This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in HSCT patients, as measured by viral load changes, worsening of upper respiratory tract infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms, the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and duration of hospitalization, incidence of secondary bacterial infection, and mortality rates. Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels achieved in the HSCT population, and the profile of viral resistance development will also be assessed.

Timeline

Start

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Primary completion

2017-04

Completion

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Outcome

Outcome not reported

Stopped: “Study is withdrawn due to company decision”

Drugs

Indications