Do you have severe itch associated with primary sclerosing cholangitis (PSC)? You may be able to participate in a research study to find out if an investigational medication called volixibat is a safe and effective treatment for itching associated with PSC and if it may improve markers associated with PSC disease progression. Compensation is provided.
Primary sclerosing cholangitis (PSC) is a rare liver disease that causes damage to the bile ducts inside and outside the liver. For many people with PSC, intense itching associated with the disease can lead to a decreased quality of life. There are currently no approved medications to treat itching in people with PSC.
The purpose of this research study is to find out if an investigational medication called volixibat is a safe and effective treatment for itching related to PSC and if it may improve markers associated with PSC disease progression. Volixibat is designed to lower circulating bile acid levels that are believed to lead to itching in patients with PSC.
COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 18 and up
- Diagnosed with large duct or small duct primary sclerosing cholangitis (PSC)
- Currently affected by itch caused by PSC
WHAT PARTICIPANTS CAN EXPECT
Following a four-week screening period, eligible participants will be randomly assigned to receive either volixibat or placebo for a period of 28 weeks. The placebo looks like volixibat but contains no medication. After this 28-week period, all participants may choose to receive volixibat for two years. Study procedures include blood draws, urinalysis, electrocardiogram, ultrasound, questionnaires, and completing an eDiary once each day.
IRB: 20202864- A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
MEET THE RESEARCHER
Mordechai Rabinovitz, MD, is a Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition at the University of Pittsburgh. A graduate of Tel-Aviv University in Israel, Dr. Rabinovitz’s research interests include assessment and treatment of chronic viral hepatitis as well as developing new therapies for non-alcoholic fatty liver disease.