Respiratory Syncytial Virus Infections Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety and Efficacy of A-60444 in Adults With RSV Infection Following Stem Cell Transplantation
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.
Clinical will be recorded daily. A-60444 PK will be studied pre-dose and at peak dose on the last day (Day 5) of dosing. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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