The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance, Using Bone Marrow Failure as a Model
Abstract
This protocol has been accruing subjects appropriately. During this report year 27 subjects were consented; 20 were enrolled; 6 were deemed 'screen failures', and 1 was withdrawn prior to enrollment. Of the 6 screen failures, 1 subject was found to have taken leucine over-the-counter; 1 was not chronically transfusion dependent as per the criteria of the study; 1 had a history of severe non-compliance; 1 had elevated liver function tests beyond the limits allowed on the study; 1 was found to be on Prednisone on review; and 1 was being treated for pancreatic insufficiency and was deemed ineligible as the absorption of the study drug with pancreatic enzyme replacement is known. Three subjects (02-003, 02-004, and 02-005) required re-consenting as their enrollment did not occur within 30 days of the signing of the original consent.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2014
- Accession Number
- AD1024510
Entities
People
- Adrianna Vlachos
Organizations
- The Feinstein Institute for Medical Research