Clinical Trial

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

Completed
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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.
Protocol Amendment History 1 change
critical Trial completed 2026-04-02
Trial Details
NCT Number NCT07049887
Lead Sponsor Ipsen
Conditions Primary Biliary Cholangitis
Enrollment 30 participants
Start Date 2025-07-16
Primary Completion 2026-02-23 (estimated)
Study Completion 2026-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-04-30