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NCT07049887

A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

Sponsor: Ipsen

View on ClinicalTrials.gov

Summary

This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.

Official title: A Multicenter Non-interventional Study for the Measurement of Scratch and Sleep Patterns Using the ADAM Sensor in Patients With Primary Biliary Cholangitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-07-16

Completion Date

2026-02-23

Last Updated

2026-04-30

Healthy Volunteers

No

Locations (3)

Arizona Liver Center

Chandler, Arizona, United States

University of Miami School of Medicine, Center for Liver Diseases

Miami, Florida, United States

UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases

Dallas, Texas, United States