Cholestatic Liver Disease Treatment with Maralixibat over a Long Term: The MERGE Study – Phase II

A Long-Term Safety Study of Maralixibat, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor, in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

Protocol Description

This multi-center research study evaluates the effectiveness, potential side effects, and how the body processes the drug maralixibat when used to treat patients with cholestatic liver disease over an extended period of time.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients with cholestatic liver disease who previously participated in and completed a maralixibat study.
Males and Females: 12 months and older

Requirements

The study drug will be given as an oral solution taken once or twice a day as determined by the study team. Each day, participants or their caregivers will be required to complete study questionnaires via their smartphone or tablet. Participants will return to clinic every 16 weeks for examinations, including blood and urine sampling, and imaging. Participants may remain in the study until the drug is commercially available, the study ends, or the patient is withdrawn from the study for other reasons.
Visits: Every 4 months
Duration: Open ended

Status: Enrolling by Invitation

Source(s) of Support

Mirum Pharmaceuticals

Primary Investigator

Robert Squires, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator Amanda Blasko, RN, BSN
412-692-5811