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Volixibat

Evaluating the Safety and Efficacy of Volixibat in Patients with Itching Caused by Primary Sclerosing Cholangitis

The VISTAS Study

The VISTAS Study is seeking adults diagnosed with PSC to evaluate whether the investigational drug volixibat is a safe and effective treatment option for cholestatic itch.

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Thinking of taking part?

  1. Check how suitable you are by looking at the information below.
  2. Check our map to see if you can get to a study site.
  3. Contact the research team for more details if you think you are suitable. Check back regularly as we are adding more contact info every day.
  4. Got a question? Our Clinical Trials Pack has lots of information about how to join clinical trials, switching hospitals for trials and what's involved.
  5. Contact us if you need any help.

About Volixibat

Volixibat blocks the main transporter protein (ileal bile acid transporter [IBAT]) that is normally responsible for bringing bile acids back into the body from the gut.

As a result, volixibat treatment is expected to lower bile acid levels in the blood which in turn may help ease itch experienced by people with PSC.

 

 

 

Download patient information leaflet (need to add link to a pdf)

FAQs

Key information

Trial Name
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (VISTAS)
ClinicalTrials.gov Identifier NCT04663308
Phase Phase 2
Intervention Volixibat (or placebo) oral capsules twice daily
Recruiting now? Yes
Participating Centres and Contact

Please see current list of sites on ClinicalTrials.gov

(Southampton General Hospital - recruiting. Email HepUroRenalResearch@uhs.nhs.uk)

Liver disease diagnosis Confirmed diagnosis of large duct or small duct PSC based on clinical guidelines
Age 18 years and older
Females: can I be pregnant? No, and breastfeeding is also not allowed
Is IBD (inflammatory bowel disease) allowed? Yes, IBD is allowed if meeting additional criteria
Is there an ALP (alkaline phosphatase) requirement? No
Is there an itch requirement? Yes, patients must have itch due to PSC to take part
Can I take UDCA (Urso)? Yes, UDCA use will be allowed if meeting additional criteria
Can I take part if I have a stent? Yes, if the bile duct stent was placed more than 12 weeks prior to the Screening visit
Are recent acute cholangitis attacks allowed? Acute cholangitis attacks are not exclusionary. Please contact the study team for more details.
Can I take part if I have had a liver transplant? No
Is cirrhosis allowed? Yes, if there is no evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
Previous studies and information (from Sponsor website)

Links to published research about this drug:

Phase 1 Drug-Interaction Loperamide Study

 

Phase 2 NASH Study

Are travel expenses covered? Travel expenses will be reimbursed. Please check with the study staff for additional information. It will not cost you to participate in the study.
Procedures and tests include:

Daily 1-minute questionnaire in a mobile phone device, and additional questionnaires at in person visit on an on-site tablet device. Blood tests, and liver transient elastography (Fibroscan).

No biopsy is required.

How many study visits? How long will each study visit be? The study period will be 10 planned study visits over 32 weeks. Some visits can be remote televisits or HomeHealth visits, at the discretion of the investigator. The duration for each on-site visit is approximately 4-6 hours.
Duration of Study (treatment duration/follow-up) At the end of the 32 weeks, participants will have the option to participate in an open-label extension period of the study where participants will receive volixibat for up to 2 additional years.
Basic design of study Randomised double-blind placebo-controlled study.
How is this intervention thought to work and what is it thought to do? Volixibat blocks the main transporter protein (IBAT) that is normally responsible for bringing bile acids back into the body from the gut. As a result, volixibat treatment is expected to lower bile acid levels in the blood which in turn may help ease itch experienced by people with PSC.
Study website Vistas PSC Study
Sponsor website Mirum Pharmaceuticals, Inc

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