Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
Status:
Withdrawn
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
The safety and tolerability of hLF 1-11 given in multiple doses has to be established first
in HSCT recipients who are at risk of developing, but have not yet developed, infectious
complications due to invasive fungal or bacterial disease. These patients are different from
healthy volunteers because they have received myeloablative treatment, which not only arrests
haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which
predispose to infections, which typically occur during the week after transplant. It is
therefore essential to know that hLF 1-11 is safe and well tolerated when given during
neutropenia and mucosal barrier injury before infections ensue.