NCT07049887Completed
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
A Multicenter Non-interventional Study for the Measurement of Scratch and Sleep Patterns Using the ADAM Sensor in Patients With Primary Biliary Cholangitis
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 9 Jun 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 23 Feb 2026
- Lead sponsor
- Ipsen
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07049887
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 16 Jul 2025 to the primary completion date, 23 Feb 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Has already been enrolled in another clinical study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona Liver Center Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University Of Miami School Of Medicine, Center For Liver Diseases Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.