Status:
COMPLETED
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
Lead Sponsor:
Arrow Therapeutics
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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.
Eligibility Criteria
Inclusion
- Patients diagnosed with RSV infection who have had a stem cell transplant.
- Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation, or who have been post-menopausal for at least two years; or are considered to be sterile due to recent chemotherapy.
- Aged between 18 and 65 years.
- Patients who have given their written informed consent to participate in the study.
- Patients who are willing and able to comply with the protocol and study procedures.
Exclusion
- Patients who have received an investigational drug within one month preceding the start of dosing.
- Patients who have a documented history of allergy to benzodiazepines.
- Patients with significant hepatic impairment (alanine transaminase \[ALT\] more than 5 x upper level of normal \[ULN\], total bilirubin more than 3 x ULN). Biochemistry data collected four weeks prior to screening is acceptable.
- Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00232635
Start Date
September 1 2005
End Date
July 1 2006
Last Update
February 12 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stephen MacKinnon
London, London, United Kingdom