Primary Biliary Cholangitis (PBC)NCT07631442
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
An observational study of Primary Biliary Cholangitis (PBC), run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Apr 2028
- Phase
- Observational
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: 30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)
Who may be able to join
- PBC diagnosis based on meeting 2 of 3 criteria:
- Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
- Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40.
- Diagnostic or compatible liver biopsy.
- Ability to provide informed consent
- Ability to complete digital questionnaires
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- Elevated alkaline phosphatase
- Abbreviations:
- alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100]
Who cannot join
- Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
- Active malignancy requiring treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University School of Medicine
Redwood City, California, 94063
About this study
Official title: Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.
Read the detailed description
Patients enrolled are intended to start a second-line therapy (2L) for control of their PBC - the choice of therapy will be at the discretion of the treating hepatologist. Once 2L therapy is initiated, the study will assess for correlations between changes in biochemistries (alkaline phosphatase, or ALP) with biometrics and PRO results.
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- liver disease, pruritis, fatigue, poor sleep, brain fog, digital health technology, biometrics, Oura ring, primary biliary cholangitis, PBC
- Medical subject headings
- Liver Cirrhosis, Biliary, Liver Diseases, Pruritus, Fatigue, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Primary Biliary Cholangitis (PBC) and an abnormal alkaline phosphatase (ALP) | Patients with an ALP >1.67x ULN will be preferentially enrolled, but all patients with an elevated ALP can be considered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Sleep Score 0 - 100 where 0 is worst sleep experience and 100 is best sleep experience
Measured: 7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
Measured: 7 months (1 month of screening and 6 months wearing device)
Total time in bed, to assess sleep quality
Number of hours per day spent in bed
Measured: 7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality
Number of hours per day spent asleep
Measured: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (REM), to assess sleep quality
Number of hours per day spent in REM (Rapid Eye Movement) sleep
Measured: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (deep), to assess sleep quality
Number of hours per day spent in deep sleep
Measured: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (light), to assess sleep quality
Number of hours per day spent in light sleep
Measured: 7 months (1 month of screening and 6 months wearing device)
Number of "get ups" during sleep, to assess sleep quality
Number of times "getting up" during the night while trying to sleep
Measured: 7 months (1 month of screening and 6 months wearing device)
Temperature deviation from baseline, to assess sleep quality
change in temperature over time during sleep cycle
Measured: 7 months (1 month of screening and 6 months wearing device)
Heart rate
Measured: 7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Measured: 7 months (1 month of screening and 6 months wearing device)
Calories burned during exercise to assess daily activity
Number of calories burned during each exercise session
Measured: 7 months (1 month of screening and 6 months wearing device)
Calories burned throughout the day to assess daily activity
total number of calories burned each day
Measured: 7 months (1 month of screening and 6 months wearing device)
Distance traveled during exercise to assess daily activity
Number of miles traveled during each exercise session
Measured: 7 months (1 month of screening and 6 months wearing device)
Number of steps to assess daily activity
total number of steps taken each day
Measured: 7 months (1 month of screening and 6 months wearing device)
Change in PBC-40 fatigue domain score in patients with PBC
The PBC-40 fatigue domain allows a potential value range of 11 to 55 with higher values denoting worse fatigue. A score of >33 identifies patients with moderate-severe fatigue and a mean change in this score by 5 points after 3 months has been used in other studies to denote clinically meaningful significance.
Measured: 7 months (1 month screening and 6 months wearing the device)
Secondary outcomes (3)
Change in alkaline phosphatase (ALP) levels
ALP levels (where lower levels reflect better control of PBC disease) will be measured in patients both before and after a second-line therapy (2L) is started.
Measured: Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
Changes in Daily Fatigue Impact Scale.
The Daily Fatigue Impact Scale measures how fatigue interferes with daily functioning. Scores range from 0 to 32, with higher numbers indicating a greater severity of fatigue.
Measured: 7 months (1 month screening and 6 months wearing the device)
Change in Epworth Sleepiness Scale (ESS) score
The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
Measured: 7 months (1 month screening and 6 months wearing the device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Aparna Goel, Stanford University
- Investigators
- Aparna Goel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631442
- Sponsor's protocol ID
- 83091
- Status last verified
- Jun 2026
- First submitted
- 4 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No