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(352) 733-0111

Mirum VLX-601

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Protocol number OCR42508
ClinicalTrials.gov ID NCT05050136
Phase Phase 2

Eligibility

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 and anti-pruritic medication 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

Lead researcher

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.