RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-16
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07049887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older at time of study enrollment.
  2. * Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
  3. * Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
  4. * Able to read and write to ensure accurate completion of electronic PRO surveys.
  5. * Able to access an internet-connected device for the completion of electronic PRO surveys.
  6. * Able to provide signed, informed consent prior to collection of data.
  1. * Has already been enrolled in another clinical study.
  2. * 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.
  3. * Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.

Contacts and Locations

Study Contact

Ipsen Clinical Study Enquiries
CONTACT
See Email
clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

Arizona Liver Center
Chandler, Arizona, 85224
United States
University of Miami School of Medicine, Center for Liver Diseases
Miami, Florida, 33136
United States
UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Ipsen

  • Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2025-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Biliary Cholangitis