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Bile Acid Sequestrant

Volixibat for Itching in Primary Sclerosing Cholangitis (VISTAS Trial)

Phase 2
Recruiting
Research Sponsored by Mirum Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through to week 28
Awards & highlights

VISTAS Trial Summary

This trial is testing a new drug to see if it can help relieve itching caused by primary sclerosing cholangitis, as well as slow the disease's progression.

Who is the study for?
This trial is for individuals aged ≥16 with Primary Sclerosing Cholangitis (PSC) who experience itching. They must understand the study and agree to its requirements, including follow-up visits. Participants can have Inflammatory Bowel Disease if they meet certain conditions and may use specific medications for PSC-related itching.Check my eligibility
What is being tested?
The study is testing Volixibat's effectiveness in treating itchiness caused by PSC and its potential impact on the disease's progression. Participants will be randomly assigned to receive either Volixibat or a placebo (a substance with no therapeutic effect).See study design
What are the potential side effects?
While not specified here, side effects of Volixibat could include typical drug reactions such as digestive issues, headaches, fatigue, or allergic responses. The exact side effects would be monitored throughout the trial.

VISTAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PSC following AASLD guidelines.
Select...
I have itching related to my liver condition, as measured by a specific test.

VISTAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
Secondary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire
Change in Primary Sclerosing Cholangitis-Specific Patient-Reported Outcome
+5 more

Side effects data

From 2015 Phase 1 trial • 84 Patients • NCT02287779
100%
Diarrhoea
22%
Pyrexia
11%
Proctalgia
11%
Abdominal discomfort
11%
Anorectal discomfort
11%
Tachycardia
11%
Vomiting
11%
Pain
11%
Headache
11%
Dry throat
11%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Volixibat 5 mg BID
Volixibat 10 mg QD
Volixibat 20 mg QD
Volixibat 2-5-10-20 mg QD
Volixibat 30 mg QD
Volixibat 40 mg QD
Volixibat 80-40-20 mg QD

VISTAS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Volixibat 80mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 80mg twice daily.
Group II: Volixibat 20mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 20mg twice daily.
Group III: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volixibat
2015
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Mirum Pharmaceuticals, Inc.Lead Sponsor
29 Previous Clinical Trials
1,446 Total Patients Enrolled

Media Library

Volixibat (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT04663308 — Phase 2
Primary Sclerosing Cholangitis Research Study Groups: Volixibat 20mg, Volixibat 80mg, Placebo
Primary Sclerosing Cholangitis Clinical Trial 2023: Volixibat Highlights & Side Effects. Trial Name: NCT04663308 — Phase 2
Volixibat (Bile Acid Sequestrant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04663308 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the projected number of participants for this clinical investigation?

"This research requires 200 volunteers who meet the specific inclusion criteria. Individuals wanting to join in on this trial can go to The Liver Institute At Methodist Dallas Medical Center located in Dallas, Minnesota or University of Minnesota situated in Minneapolis, California."

Answered by AI

Are there numerous venues conducting this trial in North America?

"Currently, 29 sites across the US are conducting this medical trial. These centres span from Dallas to Minneapolis and San Francisco to other major cities - it is wise for prospective patients to select a location closest them in order lessen travel costs."

Answered by AI

Could you provide examples of other experiments involving Volixibat?

"Presently, there are 3 active trials for Volixibat, none of which have reached the Phase 3 stage. Most research is situated in Wiesbaden, Georgia; however, 112 other sites across the globe are also running studies relating to this therapeutic agent."

Answered by AI

Has there ever before been a clinical study like this one?

"Three active clinical trials for Volixibat have been conducted across 54 cities and 7 nations since the beginning of 2020. Sponsored by Mirum Pharmaceuticals, Inc., this Phase 2 drug approval study involved 200 participants and has since seen 18327 studies completed."

Answered by AI

Has the Federal Drug Administration sanctioned Volixibat as a viable therapeutic option?

"Our team rated volixibat's safety as a 2, since the Phase 2 trial has produced limited evidence for its effectiveness but multiple rounds of data supporting its security."

Answered by AI

Is the enrollment period still open for this research trial?

"This clinical trial posted on December 18th 2020 is actively recruiting, as referenced by the latest update from October 2nd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
2020. "A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04663308.
~57 spots leftby Sep 2025
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