Gilead 102 Simtuzimab 125 mg Study Outcome

General Clinical Trials
1

For those who have not heard, the results to the clinical research study on the role of Simtuzimab as an antifibrotic therapy for the treatment of PSC recently was released. I received this from Duke University Medical Center recently. Here is a portion of the notice I received summarized.

The results of the study demonstrated that Simtuzimab was well tolerated but did NOT improve liver scarring. This was disappointing news to hear, I for one had been in the study for 2 years prior to transplant, but we must hope that one day there will be new treatments and therapies that will help in controlling fibrosis in patients with auto-immune liver diseases.

The goal of reversing liver fibrosis would be a major milestone for patients with chronic liver disease. I did find out I was getting the actual drug and not the placebo. I will say though that one big advantage for me in participating in a study like this is that I got a physical check up each month which included labs, EKG, physical exam and MRCP’s from time to time as well as the Fibroscan as well. The hardest part was giving myself that injection each week in my stomach or thigh. I believe though the close monthly checkups helped me get on the transplant list sooner as they were watching me so closely. So if another study comes up, I would encourage you to consider participating.

Mark
PSC 2011 / Liver Transplant 2015

2

Mark,

Since my initial diagnosis and ERCP w/stints inserted and then removed my labs have been exceptional. How do I keep in the loop on available trials and the requirements to participate?

Thanks and God bless your work in this forum!!

Graciously,
Bill Kamer

3

Bill,
Thanks for your message. I’m glad to hear you are doing so well. In the early years after my own PSC diagnosis my first ERCP gave me some really good relief from symptoms for a number of years before further intervention was needed. Of course everyone’s so different but I hope you will continue to do well for many years to come. There are a number of places to search out clinical trials. Here a few to consider.

  1. Check with the hepatology department at the transplant center near you about any clinical trials for PSC patients that they are participating in.
  2. Here’s a good source for current trials as well. http://pscpartners.org/clinical-trials/. PSC Partners is a very good source of information for PSC patients. These guys are doing a very good job in PSC research and advancement of educating folks about this rare disease.

I hope this helps. Keep in touch and let us know how you are doing.

Mark