Conquering Diseases

Investigational Study For Patients With Liver Cirrhosis (Cobalt)

Description

The study drug, Ocaliva (OCA), already has FDA approval but we need to gather more data about how well it works on patients with Primary Biliary Cholangitis (PBC) when given along with the usual care for this condition. Half of the study participants will get the study drug and half will get a placebo (fake pill). You cannot choose or know which pill group you belong to.

Overview

There will be 2 clinic visits to decide if you can be enrolled. In the first year there are 7 visits and 4 visits each year after that. The study doctor will tell you when and how many pills to take each week. You may need other visits if the study doctor thinks it's necessary. At these visits you will be checked by interview, physical exam, blood and urine tests for medical changes. EKGs and abdominal tests will be done at some visits.

What we're hoping for

To learn more about how well the study drug Ocaliva (OCA) works in preventing or delaying specific medical conditions or health related issues that can occur in patients with PCB.

Additional Information

ClinicalTrials.gov Identifier: NCT02308111

 Principal Investigator

Gyongyi  Szabo, MD

University of Massachusetts Medical School

 Study Contact

Donna  Giansiracusa

774-441-7648

donna.giansiracusa@umassmemorial.org

 Location

UMMS University Campus

55 Lake Ave North 

Worcester,MA 01655

508-856-8989