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

Ipsen

Status: Active, not recruiting

Conditions: Primary Biliary Cholangitis

Study type: Observational

Funder types: Industry

Identifiers

NCT07049887

CLIN-60190-466

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older at time of study enrollment.
• Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
• Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
• Able to read and write to ensure accurate completion of electronic PRO surveys.
• Able to access an internet-connected device for the completion of electronic PRO surveys.
• Able to provide signed, informed consent prior to collection of data.

Exclusion criteria

• Has already been enrolled in another clinical study.
• Has any dermatological conditions or severe comorbidities associated with pruritus as assessed by the investigators that may confound the measurement of scratch or sleep data.
• Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.