iBAT inhibition in PBC with itch
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat doses of GSK2330672 administration in patients with primary biliary cirrhosis (PBC) and symptoms of pruritus.
IRAS ID
134672
Contact name
David E Jones
Contact email
Sponsor organisation
GlaxoSmithKline research and Development Ltd
Eudract number
2012-005531-84
Clinicaltrials.gov Identifier
Research summary
Bile is produced in our livers and drains into our gut. It contains bile acids that help digest food and are then absorbed back into the body. In primary biliary cirrhosis (PBC) the tiny tubes that carry bile through the liver become inflamed. Bile acids are trapped in the liver where they cause damage. Many people with PBC suffer from a deep, persistent itch which can seriously limit their quality of life, even when their livers are working well. Studies have suggested that the bile acids cause the itch, and reducing the levels of bile acids in the body might help reduce the misery caused by itching.
This study is the first trial of a new treatment for itch in people with PBC. This blocks the process that absorbs bile acids back into the body from the gut. More bile acids leave the body in the person’s bowel motions and the levels of bile acids in the body fall. This medicine has been tested in healthy people. The main purpose of this study is to make sure that it is also safe in people with PBC and does not give them side effects. We will be looking to see if it makes a difference to how itchy people feel and making sure that it does not interfere with their other medicines. We will also measure its effect on levels of bile acids in the body and other chemicals involved in the feeling of itch. People in this study will take medicine and record how itchy they feel twice a day for eight weeks. They will attend a research unit for tests. This involves three 36-hour stays and two visits of 1-2 hours.
The new treatment has been invented by a drug company, GlaxoSmithKline (GSK), who are paying for the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0290
Date of REC Opinion
4 Nov 2013
REC opinion
Favourable Opinion