At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Volixibat (drug), Placebo (drug)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- Volixibat — drug: Oral capsules, administered twice daily. · Placebo — drug: Capsules matched to study drug without the active pharmaceutical ingredient
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 333
- Started
- 2021-09-22
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for primary biliary cholangitis
- • Phase2 - 333 participants
- • The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with primary biliary cholangitis
Where?
- • Southampton - University Hospital Southampton NHS Foundation Trust
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
- • Belfast - Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
- • London - Royal Free Hospital NHS Foundation Trust
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Provide signed agreement to take part at the screening visit as well as comply with all study visits and requirements...
- ✓Male or female, age ≥18 years at the screening visit
- ✓Confirmed diagnosis of PBC in line with the AASLD guidelines
- ✓UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
- ✓Qualified pruritus associated with PBC as assessed by Adult ItchRO
Who cannot take part
- ✗Pruritus associated with an etiology other than PBC
- ✗Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
- ✗Current causing symptoms cholelithiasis or inflammatory gallbladder disease
- ✗History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
- ✗Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
See the full criteria
Where Is This Study? (7 UK sites)
University Hospital Southampton NHS Foundation Trust
Southampton S016 6YD, United Kingdom
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
Birmingham B15 2GW, United Kingdom
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
Belfast BT12 6BA, United Kingdom
Royal Free Hospital NHS Foundation Trust
London NW3 2QZ, United Kingdom
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
