Clinical Trials Directory
We are doing this study to collect data about the use and safety of the GORE TAG Conformable Thoracic Stent Graft®. This device is approved by the FDA for the endovascular repair of medical conditions of the aorta (the large blood vessel that runs inside the chest and abdomen).
In this study, people will be treated with the Gore TBE device as part of their regular surgery planned by their doctor. The study will collect information from normal follow up visits for up to ten years. Participants will also be asked to fill out a questionnaire before surgery and again at each follow up visit to help doctors understand how they are doing over time.
If you are able to join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study drug GSK6519754, another will get 300 milligrams, and the third group will get a placebo, which has no medicine. You will get your assigned injection once every four weeks for four years. During the study, which lasts a little over four years, you will have at least fifty four visits. At these visits, you will have blood tests, body and liver scans, ultrasounds, a liver biopsy, and questionnaires to check your health and how the treatment is working.
If you can join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study medicine called GSK6519754, another group will get 300 milligrams, and the third group will get a placebo, which has no medicine. Most people will receive the study medicine. You will get the injection once every four weeks for several years. During the study, you will come to the clinic many times. At these visits, doctors will do blood tests, body and liver scans, ultrasounds, and ask you to fill out questionnaires to check your health and how the treatment is working.
Completing an 8 question survey
We are doing this study to understand how hand transplantation can help you with your daily activities compared to before the transplant.