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

NCT07631442 | Enrolling By Invitation

• 1 other identifier: 83091
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

liver disease; pruritis; fatigue; poor sleep; brain fog; digital health technology; biometrics; Oura ring; primary biliary cholangitis; PBC

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (3)

• Change in alkaline phosphatase (ALP) levels

  Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)

• Changes in Daily Fatigue Impact Scale.

  7 months (1 month screening and 6 months wearing the device)

• Change in Epworth Sleepiness Scale (ESS) score

  7 months (1 month screening and 6 months wearing the device)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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 \[Sp100\]

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Stanford University School of Medicine

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Liver Diseases; Pruritus; Fatigue; Mental Fatigue

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Aparna Goel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor in Medicine

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)