Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Primary Biliary Cholangitis (pbc)
  Cholestatic Pruritus
• Age: Between 18 Year(s) - 80 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants who have proven PBC.
  2. A female participant is eligible to participate if she is not pregnant or breastfeeding, and is either a woman of non-childbearing potential or is a woman of childbearing potential using accepted contraception method.

  
  

You may not be eligible for this study if the following are true:

• 1. Participants with recent positive COVID-19 test results, symptoms suggestive of active COVID-19 infection (e.g. fever, loss of taste or smell, cough, shortness of breath) and/or contact within the past 14 days with someone with COVID-19 are excluded for a minimum of 14 days from the test results or time of exposure, respectively, and must be symptom free before Screening procedures may begin.
  2. History or presence of hepatic decompensation.
  3. Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
  4. Infection with human immunodeficiency virus (HIV).
  5. Current clinically significant diarrhea.
  6. Active inflammatory ileal disease.
  7. Current symptomatic cholelithiasis or cholecystitis.
  8. Current diagnosis of primary skin disorders with itch symptoms.
  9. Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.
  10. Any current malignancies (including hematologic and solid malignancies).
  11. Current/previous diagnosis of colorectal cancer.
  12. History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
  13. Any current uncontrolled psychiatric condition.
  14. Initiation, discontinuation or change in dose of UDCA in the 8 weeks prior to Screening.
  15. Use of obeticholic acid within 8 weeks prior to Screening.
  16. Initiation, discontinuation or change in dose of bezafibrate or fenofibrate at any time during the 8 weeks prior to Screening.
  17. Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other SSRIs.
  18. Initiation, discontinuation or change in dose of opioids, regardless of indication, in the 8 weeks prior to Screening.
  19. Initiation, discontinuation or change in dose of colchicine, methotrexate, azathioprine, or systemic corticosteroids in the 8 weeks prior to Screening.
  20. Initiation, discontinuation, or change in dose of antihistamines used for the treatment of itching the 8 weeks prior to Screening.
  21. Administration of any other IBAT inhibitor in the 12 weeks prior to screening.