Clinical Research Study in patients with itch due to Primary Biliary Cholangitis (PBC).

The Study: GlaxoSmithKline (GSK) pharmaceuticals is running a study of a new treatment which we hope will improve itch for patients with Primary Biliary Cholangitis (PBC).

Funder:  This clinical trial is funded by GSK.

Why: Itch is common in people with PBC and currently available treatments are not always effective and have side effects. There is a need to find better treatments for itch in PBC patients.

What: GSK2330672 is being developed as a tablet to treat the PBC itch. Bile passes from the liver into the intestines where it helps with the digestion of food. Some of the bile is then taken back up into the blood and returned to the liver. GSK2330672 blocks the uptake of bile from the intestines. It is anticipated that this will allow the chemicals that cause the itch to be lost from the body in a person’s stool (‘poo’). The purpose of this study is to test whether this makes the PBC itch better. The study will test a range of doses of GSK2330672 to compare the effect, safety and how well it is tolerated by patients with moderate to severe itch due to PBC. Some of the study participants will be assigned to the placebo (dummy medication) group and will not receive study drug.

Who: PBC patients with moderate to severe itch.

Where and when: This study will take place in approximately 10 countries around the world, including approximately 9 centres in England and Scotland. Different countries and centres will start enrolling patients at different times and an up-to-date list is kept at:

https://clinicaltrials.gov/ct2/show/study/NCT02966834

The study involves 7 visits at the study site and 1 final telephone contact with the study doctor or nurse. For approximately 3 of these visits patients may also need to stay in the hospital or near the study site for over 3 hours to allow for collection of additional blood samples (the visit may last around  approximately 2-5 hours). Patients participating in this study will receive reimbursement of their travel expenses and compensation for meals and refreshments for the visits.

How: If you live in the UK and would like to find out more about this study please contact:
Zohur Miah (UK-PBC Clinical Trials Project Manager)
Email: zohur.miah@uhb.nhs.uk
Tel: 0121 371 8116

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