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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT02247934
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening
* Patient report of PSC symptoms associated with PSC diagnosis
* Able to speak, read, and understand English
* Willing and able to provide written informed consent to participate in the research study
Exclusion Criteria:
* Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis
* Patient with history of liver cirrhosis
* Patients with history of cholangiocarcinoma
* Patients who have received a liver transplant
* Patients currently enrolled in PSC clinical trials; and
* STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02247934
Study Brief:
Protocol Section:
NCT02247934