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A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary biliary cholangitis
EU CTIS ID: 2023-504660-41-00
What this study is testing
To evaluate the efficacy of volixibat versus placebo for the treatment of pruritus in participants with PBC as measured by the change in the Adult ItchRO tool in participants with PBC
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study.
- 2. Male or female, age ≥18 years at the screening visit
- 3. Confirmed diagnosis of PBC in line with the AASLD guidelines.
- 4. UDCA and anti-pruritic medication use will be allowed if meeting additional criteria.
- 5. Qualified pruritus associated with PBC as assessed by Adult ItchRO.
You likely can't join if
- 1. Chronic pruritus of other etiology that may interfere with the severity assessment of PBC-related pruritus
- 2.Evidence of decompensated cirrhosis or complications of cirrhosis (e.g., variceal bleeding or untreated esophageal/gastric varices, ascites, hepatic encephalopathy, hepatorenal syndrome).
- 3. Current symptomatic cholelithiasis or inflammatory gallbladder disease.
- 4. History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
- 5. Evidence, history, or suspicion of other liver diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
- Brazil
- Japan
- United Kingdom
- Mexico
- China
- Canada
- Israel
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States; Brazil; Japan; United Kingdom; Mexico and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.