Primary Biliary CholangitisNCT07049887
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
An observational study of Primary Biliary Cholangitis, run by Ipsen at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jul 2025to 23 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with PBC
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arizona Liver Center
Chandler, Arizona, 85224
UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases
Dallas, Texas, 75390
University of Miami School of Medicine, Center for Liver Diseases
Miami, Florida, 33136
About this study
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
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.
- Conditions
- Primary Biliary Cholangitis
- Medical subject headings
- Liver Cirrhosis, Biliary
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nocturnal Scratch Events
Defined as the total number of scratch events detected during sleep periods, monitored using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Frequency of Low- and High-Intensity Nocturnal Scratch Events
Defined as the frequency of scratch events categorized into low- and high-intensity levels during sleep periods, as detected by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Average Scratch Intensity Per Night
Defined as the average intensity of scratch events per night, calculated from data recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Hourly Frequency of Nocturnal Scratch Events During Sleep
Defined as the frequency of nocturnal scratch events occurring per hour during sleep periods, recorded using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Average Duration of Scratch Events Per Night
Defined as the average duration of scratch events occurring during sleep periods, calculated using data collected via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Total Duration of Scratch Behavior Per Patient During Sleep Periods
Defined as the total duration of scratch events recorded for each patient during sleep periods using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Total Sleep Duration (Hours)
Defined as the total duration of sleep per patient, recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Duration of Wakefulness After Sleep Onset (WASO, Minutes)
Defined as the total duration of wakefulness after the initial onset of sleep, measured using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Duration of Wakefulness During Scratch Periods
Defined as the total duration of wakefulness during scratch periods, monitored via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Average Sleep Duration Between Scratch Periods
Defined as the average duration of sleep occurring between scratch periods, as measured by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Measured: At weeks 0, 4, 8 and 12
Secondary outcomes (24)
Demographic Data: Age at Enrollment
Defined as the age of patients recorded at the time of enrollment.
Measured: At enrollment visit (Week 0, Day 1)
Demographic Data: Sex at Enrollment
Defined as the sex of patients recorded at the time of enrollment.
Measured: At enrollment visit (Week 0, Day 1)
Age at Diagnosis (As Available)
Defined as the patient's age at the time of diagnosis, as reported in their medical history.
Measured: At enrollment visit (Week 0, Day 1)
Age at First Symptoms (As Available)
Defined as the patient's age when first symptoms were reported, based on medical records or patient recollection.
Measured: At enrollment visit (Week 0, Day 1)
Time Duration Since PBC Diagnosis
Defined as the duration between the patient's initial diagnosis of PBC and the time of enrollment, as recorded in their medical history.
Measured: At enrollment visit (Week 0, Day 1)
Current PBC-Related Treatments
Defined as the treatments patients are currently receiving for PBC, including medication and other therapies, as reported at enrollment.
Measured: At enrollment visit (Week 0, Day 1)
Time Duration on Current PBC-Related Treatment
Defined as the duration for which patients have been receiving their current PBC-related treatment, as recorded during enrollment.
Measured: At enrollment visit (Week 0, Day 1)
Concomitant Medications for Itch/Scratch and/or Sleep Disturbances
Defined as the additional medications patients are currently using to manage itch/scratch and/or sleep disturbances, as reported at enrollment.
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alanine aminotransferase (ALT) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Aspartate aminotransferase (AST) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alkaline phosphatase (ALP) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Bilirubin Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Albumin Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Enhanced Liver Fibrosis (ELF) Test: Hyaluronic Acid (HA) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Procollagen Type III Amino-Terminal Propeptide (PIIINP) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Levels
Measured: At enrollment visit (Week 0, Day 1)
Baseline Liver Stiffness Measurement by Fibroscan
Measured: At enrollment visit (Week 0, Day 1)
PBC Worst Itch Numeric Rating Scale (PBC WI NRS) Score
Defined as the patient's score on the PBC WI NRS, assessing the severity of worst itch experienced during the study duration.
Measured: At weeks 0, 4, 8 and 12
PBC-40 Itch Severity Score
Defined as the patient's score on the itch severity domain of the PBC-40 questionnaire, measuring the impact of itch on their quality of life.
Measured: At weeks 0, 4, 8 and 12
Duration, degree, direction, disability, and distribution (5-D) Itch Scale
Defined as the patient's score on the 5-D Itch Scale, capturing dimensions of duration, degree, direction, disability, and distribution of itch.
Measured: At weeks 0, 4, 8 and 12
PBC-40 Fatigue Severity Score
Defined as the patient's score on the fatigue severity domain of the PBC-40 questionnaire, quantifying the impact of fatigue on their daily life.
Measured: At weeks 0, 4, 8 and 12
Sleep Disturbance Numeric Rating Scale (SD NRS) Score
Defined as the patient's score on the SD NRS, evaluating the severity of sleep disturbances experienced during the study duration.
Measured: At weeks 0, 4, 8 and 12
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form (SF)-7a Score
Defined as the patient's score on the PROMIS® Fatigue SF-7a, assessing fatigue levels and their effects on physical, mental, and social activities.
Measured: At weeks 0, 4, 8 and 12
Percentage of Patient Responses to Sibel Health System Usability Survey (SUS)
Defined as the patients' feedback on the usability of the Sibel Health System, captured through the SUS administered during enrollment. This outcome will assess user experience and satisfaction with the system.
Measured: At week 12 (End of Study Survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start16 Jul 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049887
- Sponsor's protocol ID
- CLIN-60190-466
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07049887
- Acronym / sponsor ID
- CLIN-60190-466
- Conditions
- Primary Biliary Cholangitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with PBC
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Nocturnal Scratch Events
Time frame: At weeks 0, 4, 8 and 12
Defined as the total number of scratch events detected during sleep periods, monitored using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Frequency of Low- and High-Intensity Nocturnal Scratch Events
Time frame: At weeks 0, 4, 8 and 12
Defined as the frequency of scratch events categorized into low- and high-intensity levels during sleep periods, as detected by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Average Scratch Intensity Per Night
Time frame: At weeks 0, 4, 8 and 12
Defined as the average intensity of scratch events per night, calculated from data recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Hourly Frequency of Nocturnal Scratch Events During Sleep
Time frame: At weeks 0, 4, 8 and 12
Defined as the frequency of nocturnal scratch events occurring per hour during sleep periods, recorded using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Average Duration of Scratch Events Per Night
Time frame: At weeks 0, 4, 8 and 12
Defined as the average duration of scratch events occurring during sleep periods, calculated using data collected via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Total Duration of Scratch Behavior Per Patient During Sleep Periods
Time frame: At weeks 0, 4, 8 and 12
Defined as the total duration of scratch events recorded for each patient during sleep periods using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Total Sleep Duration (Hours)
Time frame: At weeks 0, 4, 8 and 12
Defined as the total duration of sleep per patient, recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Duration of Wakefulness After Sleep Onset (WASO, Minutes)
Time frame: At weeks 0, 4, 8 and 12
Defined as the total duration of wakefulness after the initial onset of sleep, measured using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Duration of Wakefulness During Scratch Periods
Time frame: At weeks 0, 4, 8 and 12
Defined as the total duration of wakefulness during scratch periods, monitored via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Average Sleep Duration Between Scratch Periods
Time frame: At weeks 0, 4, 8 and 12
Defined as the average duration of sleep occurring between scratch periods, as measured by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
24 secondary outcomes
Demographic Data: Age at Enrollment
Time frame: At enrollment visit (Week 0, Day 1)
Demographic Data: Sex at Enrollment
Time frame: At enrollment visit (Week 0, Day 1)
Age at Diagnosis (As Available)
Time frame: At enrollment visit (Week 0, Day 1)
Age at First Symptoms (As Available)
Time frame: At enrollment visit (Week 0, Day 1)
Time Duration Since PBC Diagnosis
Time frame: At enrollment visit (Week 0, Day 1)
Current PBC-Related Treatments
Time frame: At enrollment visit (Week 0, Day 1)
Time Duration on Current PBC-Related Treatment
Time frame: At enrollment visit (Week 0, Day 1)
Concomitant Medications for Itch/Scratch and/or Sleep Disturbances
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alanine aminotransferase (ALT) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Aspartate aminotransferase (AST) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alkaline phosphatase (ALP) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Bilirubin Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Albumin Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Enhanced Liver Fibrosis (ELF) Test: Hyaluronic Acid (HA) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Procollagen Type III Amino-Terminal Propeptide (PIIINP) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Stiffness Measurement by Fibroscan
Time frame: At enrollment visit (Week 0, Day 1)
PBC Worst Itch Numeric Rating Scale (PBC WI NRS) Score
Time frame: At weeks 0, 4, 8 and 12
PBC-40 Itch Severity Score
Time frame: At weeks 0, 4, 8 and 12
Duration, degree, direction, disability, and distribution (5-D) Itch Scale
Time frame: At weeks 0, 4, 8 and 12
PBC-40 Fatigue Severity Score
Time frame: At weeks 0, 4, 8 and 12
Sleep Disturbance Numeric Rating Scale (SD NRS) Score
Time frame: At weeks 0, 4, 8 and 12
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form (SF)-7a Score
Time frame: At weeks 0, 4, 8 and 12
Percentage of Patient Responses to Sibel Health System Usability Survey (SUS)
Time frame: At week 12 (End of Study Survey)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cholangitis, run by Ipsen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Nocturnal Scratch Events (time frame: At weeks 0, 4, 8 and 12). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.