An observational study in Primary Biliary Cholangitis (PBC), sponsored by Stanford University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Stanford University · Observational
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.
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.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 30 is below the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PBC diagnosis based on meeting 2 of 3 criteria:
alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100]
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an ALP \>1.67x ULN will be preferentially enrolled, but all patients with an elevated ALP can be considered.
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
Time frame: 7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
Time frame: 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
Time frame: 7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality
Number of hours per day spent asleep
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 months (1 month of screening and 6 months wearing device)
Heart rate
Time frame: 7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 7 months (1 month screening and 6 months wearing the device)
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.
Time frame: 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.
Time frame: 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.
Time frame: 7 months (1 month screening and 6 months wearing the device)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.