Frequently Asked Questions About The OPTIMAL Study

What happens during the immunosuppression withdrawal phase?

During the immunosuppression withdrawal phase your dose of anti-rejection medication(s) will be slowly reduced. The research staff will tell you when and how to do this. It will take between 24 and 45 weeks to completely stop your anti-rejection medication(s). You will have a study visit either in person or by phone every time your study doctor feels you are ready to lower your anti-rejection medication dose.

What are the risks of undergoing immunosuppression withdrawal?

The most serious risk of lowering your dose of anti-rejection medication during the immunosuppression withdrawal phase is rejection. Rejection can occur at any point during the study and happens when your immune system causes damage to the transplanted liver. The first sign of liver rejection is most often a change in liver test results. If your liver tests show these changes, additional liver tests and possibly a liver biopsy may needed.

What are the potential benefits of undergoing the immunosuppression withdrawal phase?

If you successfully stop taking anti-rejection medications, you might benefit by not experiencing some of the common side effects of anti-rejection medications such as infection, kidney problems, diabetes, and cancer. You might also benefit from financial savings of not paying for anti-rejection medications. However, there may be no direct medical benefit to you.

How likely is it that I will experience rejection during the immunosuppression withdrawal phase?

In previous research studies, about half of the participants are able to stop their anti-rejection medication(s) completely without experiencing organ rejection. So there is approximately 50% chance of experiencing rejection of the transplanted organ.

What happens if I experience rejection during or after the immunosuppression withdrawal phase?

If you experience rejection your physician will treat you for rejection as he/she thinks best. In almost all cases rejection that occurs during drug withdrawal is easily treated without any lasting effects to the liver. However it is possible that after treatment for rejection, you would be taking more anti-rejection medicine than before.

If the treatment for rejection does not work, the liver could fail. If the liver fails, another liver transplant may be needed in order to live. It is possible that you could die while waiting for another liver transplant. If the treatment for rejection works, your liver can fully recover from rejection.

Liver biopsies are part of this study. What are the risks?

A liver biopsy is a procedure used to obtain a small piece of liver tissue for analysis. It is possible that you will have more liver biopsies than if you were not participating in an experimental study, even if your liver function is fine.

You will receive drugs to prevent pain and discomfort during the procedure. You may have pain even after these medications. Potential risks of liver biopsies include drug reactions, bleeding, accidental puncture of other organs, infection, and complications from receiving blood or blood components if a transfusion should become necessary. There is also a very low risk of death ranging between 1 in 1000 to 1 in 10,000 biopsies (0.1% to 0.01%). The most common risk is bleeding. The risk of bleeding ranges from 4 to 5 in 1000 biopsies (0.35% to 0.5%). Your study doctor will do all that is possible to avoid these risks; however, some risks may require medical or surgical care after the biopsy.