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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)

Clinical Trial Details

This clinical trial is to evaluate the experimental (investigational) study drug Volixibat in men or women who have been diagnosed with Cholestatic Pruritus (itching) with Primary Sclerosing Cholangitis (PSC). PSC is a disease of the bile ducts, which carry the digestive bile acid (used by the body to help with digestion) from your liver to your small intestine. In PSC, inflammation causes scars within the bile ducts. These scars make the ducts hard and narrow and gradually cause serious liver damage.

Volixibat is considered to be experimental meaning it is not approved by the U.S. Food and Drug Administration (FDA) or any worldwide regulatory body. At this time there is no approved medicine to treat itching in patients with PSC. In research studies, Volixibat has shown to lower circulating bile acid levels that are believed to lead to the itching in patients with PSC.

This study is designed to compare the effects of the study drug Volixibat with placebo to see which is better or is safer than having no treatment.

   This clinical trial will be conducted in 3 parts:
   1. Part 1: Participants will be randomized (like a flip of coin) into one of the following study drug groups for 24 weeks:

  •     Volixibat 20mg twice a day
  •     Volixibat 80 mg twice a day
  •     Placebo (inactive ingredient) twice a day

   2. Part 2: Participants will receive Volixibat twice a day or placebo.
   3. Part 3 Open-Label Extension: All eligible participants who choose to continue will receive Volixibat 20mg.

   This study requires participants to visit the clinic over a period of approximately 56 weeks.

   Study participants will be compensated for their time.

Key Eligibility: 
  • Men and women who are 18 years of age and older.
  • Patients with been diagnosed with Cholestatic Pruritus with Primary Sclerosing Cholangitis.

Detailed eligibility reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2011022930

ClinicalTrials.gov:

NCT04663308

Sponsor:

VLX-301

Status

Open to Enrollment

Age Group

Adult

Sponsor