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IBAT Inhibitor

Long-Term Safety of Maralixibat for Cholestatic Liver Disease (MERGE Trial)

Phase 2

Waitlist Available

Research Sponsored by Mirum Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to approximately 3 years

Awards & highlights

MERGE Trial Summary

This trial will test the long-term safety of maralixibat in patients with cholestatic liver diseases.

Who is the study for?

This trial is for individuals who have previously participated in a maralixibat study for cholestatic liver disease, including conditions like Alagille Syndrome and Biliary Atresia. Participants must be at least one year old, able to give consent, and agree to use contraception if of childbearing potential. Those with adverse reactions leading to previous discontinuation or conditions that may affect safety or compliance are excluded.Check my eligibility

What is being tested?

The study tests the long-term safety of maralixibat (MRX-800) in treating various forms of cholestatic liver disease. It's designed for those who've completed earlier phases of maralixibat trials and will involve regular check-ins via email or phone.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants from prior studies would only be excluded if they had serious adverse events related to maralixibat that led them to stop taking it permanently.

MERGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of reported adverse events AEs

Secondary outcome measures

Change from maralixibat baseline over the course of the study in mean total serum bilirubin

Change from maralixibat baseline over the course of the study in the weekly average morning ItchRO(Obs)™ frequency score (ALGS and PFIC)

Change from maralixibat baseline over the course of the study in the weekly average morning ItchRO(Obs)™ severity score (ALGS and PFIC)

+4 more

Side effects data

From 2022 Phase 3 trial • 93 Patients • NCT03905330

57%

Diarrhoea

36%

Pyrexia

21%

Abdominal pain

17%

Rhinorrhoea

15%

Blood bilirubin increased

15%

Cough

13%

Influenza

13%

Alanine aminotransferase increased

11%

Nasopharyngitis

11%

Pruritus

Vitamin E decreased

Constipation

Vitamin D deficiency

Vitamin D decreased

Gastroenteritis

Coronavirus infection

Upper respiratory tract infection

Vomiting

Vitamin E deficiency

Urinary tract infection

Abdominal pain upper

International normalised ratio increased

Cholestasis

Idiopathic pneumonia syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Maralixibat

Placebo

MERGE Trial Design

1Treatment groups

Experimental Treatment

Group I: MaralixibatExperimental Treatment1 Intervention

Participants will all receive Maralixibat oral solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Maralixibat

2015

Completed Phase 3

~260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mirum Pharmaceuticals, Inc.Lead Sponsor

29 Previous Clinical Trials

1,594 Total Patients Enrolled

1 Trials studying Cholestatic Liver Disease

12 Patients Enrolled for Cholestatic Liver Disease

Media Library

Maralixibat (IBAT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04168385 — Phase 2

Cholestatic Liver Disease Research Study Groups: Maralixibat

Cholestatic Liver Disease Clinical Trial 2023: Maralixibat Highlights & Side Effects. Trial Name: NCT04168385 — Phase 2

Maralixibat (IBAT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04168385 — Phase 2

Frequently Asked Questions

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

How many research centers are conducting this investigation in the urban area?

"This clinical trial has 7 recruitment points, including the Children Hospital of Pittsburgh in Pittsburgh,Children's Hospital Los Angeles in LA and Baylor College of Medicine/Texas Children's Hospital in Houston. Additionally, there are 4 other sites hosting trials."

Answered by AI

Are there still openings for participation in this research project?

"According to information posted on clinicaltrials.gov, this particular medical research project is no longer accepting participants. It was initially made available in January of 2019 and its most recent update was 3 years later - nevertheless, there are currently 284 other trials that do need volunteers."

Answered by AI

Can you provide a synopsis of the previous research performed on Maralixibat?

"Currently, 4 trials are ongoing for Maralixibat. One of those is a Phase 3 study. While located in Zapopan and Louisiana respectively, there are 81 other sites where this medication can be tested on patients."

Answered by AI

What potential health risk factors are associated with using Maralixibat?

"Our team at Power awarded Maralixibat a safety score of 2, given that Phase 2 trials have established some evidence for its safety but no proof of efficacy."

Answered by AI

Does this clinical experiment constitute a pioneering endeavor?

"Currently, there are four ongoing trials of Maralixibat in progress across 26 cities and 20 countries. This pharmaceutical therapy was originally launched back in 2019 with the sponsorship of Mirum Pharmaceuticals, Inc., which enrolled 52 participants to complete Phase 2 drug approval stages. Since then, 10 additional studies have been completed."

Answered by AI

To what extent is enrollment being accepted for this research initiative?

"Unfortunately, the recruitment period for this trial has come to a close. Initially posted on January 16th 2019 and last edited on January 19th 2022, there are now 280 trials searching for patients with liver diseases and 4 studies looking for participants to test Maralixibat."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

2020. "MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04168385.

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