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VISTAS Trial

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

Updated 17 June 2024

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

Update 17 June 2024

Based on a planned early look into the safety and efficacy data for volixibat in PSC, an independent data review committee has recommended that VISTAS continues to the final stage of the study at a specified dose (20mg). This is positive news, and means that no concerns were identified around safety and suggests that there is confidence that volixibat is helping with PSC 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 is an investigational medicinal product that is designed to block 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.

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 Worldwide: please see current list of sites on ClinicalTrials.gov

UK: see PSC Support map (and in FAQs above)

Liver disease diagnosis Confirmed diagnosis of large duct or small duct PSC based on clinical guidelines
Age 18 years and older 18 years and above (16 years and older at selected sites)
Females: can I be pregnant? No, you must use a reliable form of birth control while taking part of this study and breastfeeding is also not allowed.
Is IBD (inflammatory bowel disease) allowed? Yes, IBD is allowed if meeting additional criteria
Is PSC with AIH (autoimmune hepatitis) allowed? Yes, PSC with or without AIH 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 Day 1
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

 

Interim result announcement for VISTAS (17 June 2024)

 

Interim result announcement (slide deck) for VANTAGE (PBC Study) (17 June 2024)

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 visits 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 blinded study period will be 10 planned study visits over 32 weeks. Some visits can be remote televisits or virtual 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) Study participation will last 7~8 months with the option to continue in the long-term extension phase, where eligible participants will receive the investigational medication for an indefinite amount of time.
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 is designed to block 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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