AGT4HB - Viral Vector for Gene Transfer in Subjects with Hemophilia B

Dr. Radulescu will serve as the University of Kentucky Research Foundation (UKRF) principal investigator (PI) for this study. UKRF PI shall monitor the participant, report and monitor all adverse events in a timely fashion for the study. UKRF PI shall report all adverse events, unexpected or anticipated events to the St. Jude PI as soon as UKRF PI becomes aware of them, and maintain surveillance of all enrolled subjects. UKRF PI shall continue to monitor risk and benefit throughout the trial, reporting any change in the risk-benefit ratio to the study subject and to the St. Jude PI. UKRF PI shall oversee the local staff who will participate in this study to assure all required care, follow-up, and study forms are accurately completed, laboratory samples are procured and prepared as required, and forms and laboratory samples sent by imposed deadlines to the Core site. UKRF PI will oversee IRB submission and correspondence regarding progress, including enrollment, adverse events, and termination of study, as appropriate. Additional reporting may be requested by the St. Jude PI in order to meet agency requirements.