Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT04265235
Eligibility Criteria:
Inclusion Criteria:
* 18 Years Old
* A confirmed diagnosis of PBC through clinical observation as per guidance of BSG/ EASL
* Fatigue Impact Scale \>40
* Access to a SMART Phone or Computer
Exclusion Criteria:
* Decompensated PBC with the following clinical signs:
* Moderate Ascites
* A Bilirubin of \>50
* Variceal Bleed \< 6 Months
* Encephalopathic
* Refractory Pruritis (Judged by PI)
* Cardiovascular Instability (Judged by PI)
* Untreated Vitamin Deficiency
* Untreated hypothyroidism
* Untreated Coeliac Disease
* WHO Performance Status \> 3
* History of Unexplained Falls
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04265235
Study Brief:
Protocol Section:
NCT04265235