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Enrolling by Invitation

NCT Number: NCT07631442

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

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.

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Key information

Conditions

Primary Biliary Cholangitis (PBC) Behavior Behavioral Symptoms Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fatigue Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Mental Fatigue Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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]

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Sleep Score 0 - 100 where 0 is worst sleep experience and 100 is best sleep experience

  2. SpO2 (saturation of peripheral oxygen) levels to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

  3. Total time in bed, to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in bed

  4. Total sleep, to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent asleep

  5. Sleep stage time series (REM), to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in REM (Rapid Eye Movement) sleep

  6. Sleep stage time series (deep), to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in deep sleep

  7. Sleep stage time series (light), to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in light sleep

  8. Number of "get ups" during sleep, to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of times "getting up" during the night while trying to sleep

  9. Temperature deviation from baseline, to assess sleep quality

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    change in temperature over time during sleep cycle

  10. Heart rate

    Time frame: 7 months (1 month of screening and 6 months wearing device)

  11. Respiratory rate

    Time frame: 7 months (1 month of screening and 6 months wearing device)

  12. Calories burned during exercise to assess daily activity

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of calories burned during each exercise session

  13. Calories burned throughout the day to assess daily activity

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    total number of calories burned each day

  14. Distance traveled during exercise to assess daily activity

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    Number of miles traveled during each exercise session

  15. Number of steps to assess daily activity

    Time frame: 7 months (1 month of screening and 6 months wearing device)

    total number of steps taken each day

  16. Change in PBC-40 fatigue domain score in patients with PBC

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

    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.

Secondary outcomes

  1. Change in alkaline phosphatase (ALP) levels

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

    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.

  2. Changes in Daily Fatigue Impact Scale.

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

    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.

  3. Change in Epworth Sleepiness Scale (ESS) score

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

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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