NCT07631442Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 4 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Stanford University
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07631442
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
- Active malignancy requiring treatment
Criteria the registry did not label
- 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 \[Sp100\]
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Redwood City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.