A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
Objectives
Primary Objectives:
- Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in
post-stem cell transplant patients with RSV infection.
- Main Study: To determine the antiviral effect of oral A-60444 versus placebo in
post-stem cell transplant patients with RSV infection and to assess the safety of oral
A-60444 in post-stem cell transplant patients with RSV infection.
Secondary Objectives:
- To study the pharmacokinetics of A-60444 in the presence of concomitant medications such
as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV
infection.
Sample Size: Six patients will be included in the open, pilot phase of the study and there is
an option to include a further 22 patients into the main, placebo-controlled study, depending
on the pilot study findings. An independent Data Safety Monitoring Board will assess the
findings of the pilot study.