COVID-19 (Coronavirus)

VISTAS Study

Condition: Primary sclerosing cholangitis

Eligibility

Key Inclusion Criteria (Core Study):

  • At least 18 years old
  • Confirmed diagnosis of primary sclerosing cholangitis (PSC)
  • Qualified pruritus reflected by an average daily Adult ItchRO score ≥4 overall

Key Exclusion Criteria (Core Study):

  • Pruritus associated with an etiology other than PSC
  • Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
  • Presumptive or diagnosed ascending cholangitis within 12 weeks of screening through Day 1

Full Study Name

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 Sclerosing Cholangitis (VISTAS) (IRB no. 00001166)

Summary

The purpose of this study is to evaluate the investigational use of a drug called volixibat for the treatment of pruritis (itching) associated with primary sclerosing cholangitis (PSC). In the first part of the study (“Core Study”), volixibat will be compared with a placebo (inactive substance) for a period of 28 weeks. Between 50% and 67% of participants will be randomly assigned to receive volixibat. In the next part of the study, (“Open-Label Extension), all eligible participants who choose to continue will receive volixibat for up to 2 years. Researchers will evaluate the effects of volixibat (good and bad) against the effects of placebo and will watch carefully for any side effects and/or benefits.

Principal Investigator
Contact

Kelly DeLarosa, MSPA
Phone: 310-423-2743
Email: kelly.delarosa@cshs.org