Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232635
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2005-10-04
Brief Title:
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus RSV Infection Following HSCT
Sponsor:
Arrow Therapeutics
Organization:
Arrow Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None