Trial · NCT07906639
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in PBC-40 Fatigue Domain Score | Baseline and Months 3, 6 and 12 | The PBC-40 Fatigue Domain assesses fatigue and its impact on daily functioning in participants with primary biliary cholangitis. Higher scores indicate greater fatigue burden. |
| Primary | Change From Baseline in PROMIS Fatigue Short Form 7a Score | Baseline and Months 3, 6 and 12 | The PROMIS Fatigue Short Form 7a is a 7-item participant-reported questionnaire assessing the frequency, severity and impact of fatigue during the past 7 days. Higher T-scores indicate greater fatigue. |
| Secondary | Baseline Age of Participants | Baseline | |
| Secondary | Number of Participants by Sex | Baseline | |
| Secondary | Number of Participants by Race | Baseline | |
| Secondary | Number of Participants by Ethnicity | Baseline | |
| Secondary | Number of Participants by Geographic Location | Baseline | |
| Secondary | Time Since Primary Biliary Cholangitis Diagnosis | Baseline | |
| Secondary | Number of Participants by Primary Biliary Cholangitis Disease Severity | Baseline | |
| Secondary | Baseline Alkaline Phosphatase Level | Baseline | |
| Secondary | Baseline Alanine Aminotransferase Level | Baseline | |
| Secondary | Baseline Aspartate Aminotransferase Level | Baseline | |
| Secondary | Baseline Total Bilirubin Level | Baseline | |
| Secondary | Number of Participants by Primary Biliary Cholangitis-related Medication History | Baseline | |
| Secondary | Change From Baseline in WPAI-SHP Absenteeism Score | Baseline and Months 3, 6 and 12 | The Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) absenteeism domain assesses work time missed because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment. |
| Secondary | Change From Baseline in WPAI-SHP Presenteeism Score | Baseline and Months 3, 6 and 12 | The WPAI-SHP presenteeism domain assesses impairment while working because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment. |
| Secondary | Change From Baseline in WPAI-SHP Overall Work Impairment Score | Baseline and Months 3, 6 and 12 | The WPAI-SHP overall work impairment domain assesses the combined impact of absenteeism and impairment while working because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment. |
| Secondary | Change From Baseline in WPAI-SHP Activity Impairment Score | Baseline and Months 3, 6 and 12 | The WPAI-SHP activity impairment domain assesses impairment in regular daily activities, other than paid work, because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater activity impairment. |
| Secondary | Change From Baseline in PBC-40 Emotional Domain Score | Baseline and Months 3, 6 and 12 | The Primary Biliary Cholangitis 40-item questionnaire (PBC-40) Emotional Domain assesses the emotional impact of primary biliary cholangitis. Higher scores indicate greater impairment. |
| Secondary | Change From Baseline in PBC-40 Social Domain Score | Baseline and Months 3, 6 and 12 | The PBC-40 Social Domain assesses the impact of primary biliary cholangitis on social functioning and daily life. Higher scores indicate greater impairment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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