Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Biliary Cholangitis (PBC)

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)

Description

• Inclusion Criteria:

  1. PBC diagnosis based on meeting 2 of 3 criteria:

     1. Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
     2. 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.
     3. Diagnostic or compatible liver biopsy.
  2. Ability to provide informed consent
  3. Ability to complete digital questionnaires
  4. 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]

Exclusion Criteria:

1. Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
2. Active malignancy requiring treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality		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	7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality	Number of hours per day spent asleep	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	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	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	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	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	7 months (1 month of screening and 6 months wearing device)
Heart rate		7 months (1 month of screening and 6 months wearing device)
Respiratory rate		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	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	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	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	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.	7 months (1 month screening and 6 months wearing the device)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	7 months (1 month screening and 6 months wearing the device)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Aparna Goel, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: fatigue; liver disease; PBC; pruritis; brain fog; primary biliary cholangitis; Oura ring; digital health technology; poor sleep; biometrics
• Additional Relevant MeSH Terms: Pathologic Processes; Behavioral Symptoms; Digestive System Diseases; Skin Manifestations; Biliary Tract Diseases; Skin Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Signs and Symptoms; Fatigue; Liver Diseases; Liver Cirrhosis, Biliary; Pruritus; Mental Fatigue
• Other Study ID Numbers: 83091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No