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Tests treatment safety and results for Primary Biliary Cholangitis
Official title A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
ClinicalTrials.gov ID: NCT05050136
What this study is testing
What is Volixibat?
Volixibat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary biliary cholangitis.
Also referred to as SHP626.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Coronado, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Fort Myers, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Dalton, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Iowa City, Iowa, United States
- Baton Rouge, Louisiana, United States
- Shreveport, Louisiana, United States
+ 98 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coronado, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Fort Myers, Florida, United States and 112 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.