Evaluating a new drug for itching in patients with Primary Biliary Cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of an investigational drug called volixibat in treating pruritus, or itching, associated with Primary Biliary Cholangitis (PBC). Participants will receive either volixibat or a placebo to determine the drug's impact on itching and potential effects on disease progression. The study will include adults aged 18 and older with a confirmed diagnosis of PBC and qualified pruritus. The trial will follow participants through various study visits to monitor their response to the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
* 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

Exclusion Criteria:

* Pruritus associated with an etiology other than PBC
* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
* Current symptomatic 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
* History of Liver transplantation

Where it's running

• Hopital Claude Huriez-Digestive system disease clinic
  Lille, France Recruiting
• Southern California Research Center
  Coronado, California, United States Terminated
• Cedars Sinai Medical Center
  Los Angeles, California, United States Active not recruiting
• University of California Los Angeles
  Los Angeles, California, United States Active not recruiting
• UC Davis
  Sacramento, California, United States Active not recruiting
• University of Colorado
  Aurora, Colorado, United States Active not recruiting

+80 more sites. See ClinicalTrials.gov for the full list.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Swiss Primary Biliary Cholangitis Cohort

  This project will collect medical information and yearly blood samples from adults in Switzerland with primary biliary cholangitis to help understand its course and outcomes.

  Recruiting at 13 sites Fondazione Epatocentro Ticino · Lugano, Canton Ticino and 12 other locations · NCT03146910

• Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)

  This study tests whether combining seladelpar with cilofexor helps people with primary biliary cholangitis more than seladelpar alone or placebo.

  Recruiting at 4 sites Phase 2 Gilead Sciences · Colorado Springs, Colorado and 3 other locations · NCT07841977

• Austrian PBC Registry

  This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.

  Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

  This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.

  Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

  This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.

  Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.