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Bile Acid Sequestrant

Volixibat for Primary Biliary Cholangitis (VANTAGE 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

Qualified pruritus associated with PBC as assessed by Adult ItchRO

Confirmed diagnosis of PBC in line with the AASLD guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 28

Awards & highlights

VANTAGE Trial Summary

This trial is testing a new drug to see if it can help with itching caused by PBC, as well as potentially slowing down the disease.

Who is the study for?

This trial is for adults over 18 with itching due to Primary Biliary Cholangitis (PBC), as per AASLD guidelines. Participants must sign a consent form and follow study procedures. Those on UDCA or anti-itch meds can join if they meet extra rules. People with certain bowel surgeries, other liver diseases, non-PBC related itching, or severe cirrhosis cannot participate.Check my eligibility

What is being tested?

The study tests Volixibat's effectiveness in treating PBC-related itching and its impact on the disease's progression. Participants will either receive Volixibat or a placebo (a substance with no active drug) to compare outcomes between the two groups.See study design

What are the potential side effects?

While specific side effects of Volixibat are not listed here, common side effects may include digestive issues since it targets bile acid processes linked to PBC and pruritus.

VANTAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have itching due to primary biliary cholangitis.

Select...

I have been diagnosed with primary biliary cholangitis according to AASLD guidelines.

VANTAGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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

Pruritus

Secondary outcome measures

Fatigue

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire

Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40)

+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%

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

VANTAGE 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirum Pharmaceuticals, Inc.Lead Sponsor

29 Previous Clinical Trials

1,466 Total Patients Enrolled

Media Library

Volixibat (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT05050136 — Phase 2

Primary Biliary Cirrhosis Research Study Groups: Volixibat 20mg, Volixibat 80mg, Placebo

Primary Biliary Cirrhosis Clinical Trial 2023: Volixibat Highlights & Side Effects. Trial Name: NCT05050136 — Phase 2

Volixibat (Bile Acid Sequestrant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050136 — Phase 2

Frequently Asked Questions

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

Can people sign up for this clinical trial right now?

"The listing on clinicaltrials.gov verifies that this study is open for enrollment and actively recruiting patients. This trial was first announced on September 22nd, 2021 and has since been updated on November 7th, 2022. A total of 260 individuals are needed to participate across 19 different research sites."

Answered by AI

Have patients undergone this treatment before as part of a clinical trial?

"2020 was the first year that Volixibat appeared in any clinical trials. Mirum Pharmaceuticals, Inc. sponsored the very first study which took place that same year. This initial trial involved 200 patients and after its success Volixibat received Phase 2 drug approval. Presently, there are 3 active studies involving this medication being conducted in 50 cities spread out over 6 countries."

Answered by AI

How many people are signing up to participate in this research?

"Mirum Pharmaceuticals, Inc. is sponsoring a clinical trial that will take place at Covenant Metabolic Specialists in Fort Myers, Florida and Advanced Research Institute, Inc in New Port Richey, Utah. In order to begin the study, 260 patients who meet the inclusion criteria are needed."

Answered by AI

Are there any short-term or long-term dangers associated with Volixibat?

"Volixibat's safety was given a score of 2 by our team at Power. This is because, although there is data supporting Volixibat's safety, there is currently no evidence that it is an effective medication."

Answered by AI

Does Volixibat have a history of being tested in other medical studies?

"The first clinical trials for volixibat were completed in 2020 at Universitätsklinikum Schleswig-Holstein - Campus Kiel. As of now, a total of 18291 have been completed. Presently, there are 3 more underway with several taking place in Fort Myers, Florida."

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 Biliary Cholangitis

2021. "A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050136.

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