I am considering participating in a phase 3 trial for a new medication to help treat PSC. It is my understanding that there are currently no meds on the market approved for treatment of PSC. The manufacturer is Gilead and they are hoping this med will help slow the progress of fibrocity in the liver and thus reduce the need for a future transplant.
I’m looking to this group for advice, opinions, and/or any experience with clinical trials. This is all new to me. It’s a 2 year study with liver biopsies at the beginning and the end of the study, lots of bloodwork, ekgs, mrcp’s, fibroscans, etc.
Anyone out there have any experience with clinical trials? Advice? I’m a 45 year old male that was diagnosed about 9 months ago and I’m just in the early stages of PSC with no IBD (yet).
Hello. I am glad you are considering participating in the trial by Gilead Science. I was in phase 2 trials for the same goal and was almost through the 2 year trial when I got transplanted. I tell you one thing that helped me immensely. At that time I did not have health insurance, but was getting labs monthly, regular EKG’s, MRCP’s, FibroScans and Biopsies. Even though the results are blind studies they will give you copies of all your test results if you ask. Every time I got labs back I would scan those and send to my hepatologist. It really helped him keep a closer eye on my PSC progression which proved vital there at the end. I did finally get health insurance thankfully before transplant and everything worked out well. I think it’s a good thing for you to try. You get to ask any question of the PA or doctor that you see each time whereas you don’t see your hepatologist every month. It really came in handy and was done through the same transplant center where I was getting all my medical care and finally the transplant. I was 50-51 at the time when I went through the trials. Good luck. I’m glad to answer any questions you may have.
Look forward to hearing good news from you.
God bless you.