VISTAS Study

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.


Inclusion Criteria

  • Provide freely signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
  • Subjects aged ≥18 years.
  • Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
  • Qualified pruritus associated with PSC as assessed by Adult ItchRO.
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Study Location(s)

Beverly

More about this Clinical Trial

Full 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 Sclerosing Cholangitis

Details
Disease Type/Condition

Hepatology

Principal Investigator

Ayoub, Walid

Co-Investigators

Alexander Kuo

Age Group

Adult

Phase

II

IRB Number

STUDY00001166

ClinicalTrials.gov ID

NCT04663308

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Hepatology

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II

IRB Number

VLX-301

ClinicalTrials.gov ID

NCT04663308

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?