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:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03630718
Eligibility Criteria:
Inclusion Criteria:
* Women from 18 to 75 years old,
* Diagnosis of primary biliary cholangitis (PBC) according to recognized criteria (EASL 2017),
* Medically stable under treatment with UDCA initiated for at least 6 months, ie medically stable on the basis of liver biological parameters (no increase of more than 20% in bilirubin, ALP and transaminases) and absence of disabling pruritus (permanent and EVA\> 6/10 or scratching lesions),
* Presenting a significant level of fatigue (fatigue score on PBC-40\>= 33),
* Understanding the French language,
* Availability and ability of the patient to access an internet network terminal to answer the online questionnaires of the study,
* Signed consent form.
Exclusion Criteria:
* Presence of cirrhosis with a Child-Pugh B or C,
* Presence of disabling pruritus (permanent, or EVA\>= 7/10 in the last 3 weeks, or objectivable scratching skin lesions),
* Patient on liver transplantation waiting list or total bilirubin\> 50 μmol / L (3 mg / dL), or recent complication (\<6 months) of cirrhosis (ascites, hepatic encephalopathy, rupture bleeding) of esophageal varices),
* Untreated depressive disorder,
* Any comorbidity not medically controlled (i.e. all dosage changes \<3 months due to a control of the associated pathology deemed insufficient by the referring physician) or life-threatening in the medium term (within 2 years).
* Psychiatric disorder modifying the relationship to the reality
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03630718
Study Brief:
Protocol Section:
NCT03630718