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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.
Must not have
Evidence, history, or suspicion of other liver diseases
Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through to week 28

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have liver disease.
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I have or might have severe liver damage or have had liver failure events.
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I have had surgery on my small intestine or related areas that might affect liver and intestine circulation.
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I have had a liver transplant.
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I have itching not caused by primary sclerosing cholangitis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
Secondary study objectives
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire

Side effects data

From 2015 Phase 1 trial • 84 Patients • NCT02287779
100%
Diarrhoea
22%
Pyrexia
11%
Abdominal discomfort
11%
Proctalgia
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

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Arm 1: Volixibat Selected Dose 20mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 20mg twice daily.
Group II: Part 1 Arm 2: Volixibat 80mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 80mg twice daily.
Group III: Part 1 Arm 1: Volixibat 20mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 20mg twice daily.
Group IV: Part 1 Arm 3: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Group V: Part 2 Arm 2: 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
31 Previous Clinical Trials
101,537 Total Patients Enrolled

Media Library

Volixibat (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT04663308 — Phase 2
Primary Sclerosing Cholangitis Research Study Groups: Part 1 Arm 1: Volixibat 20mg, Part 1 Arm 2: Volixibat 80mg, Part 1 Arm 3: Placebo, Part 2 Arm 1: Volixibat Selected Dose 20mg, Part 2 Arm 2: 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
~25 spots leftby Sep 2025
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