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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00805805
Eligibility Criteria:
Inclusion Criteria:
* Generally medically healthy
* Age 18 and older
* Documented primary biliary cirrhosis
* Alkaline phosphatase \> 137
Exclusion Criteria:
* Severe liver decompensation
* Requirement for renal dialysis
* Pregnancy or nursing
* Meld score \> 15 (13-15 will require a physician's clinical judgment)
* Uncontrolled congestive heart failure
* Severe diabetic neuropathy
* Severe pulmonary disease
* Advanced cancer
* Requirement for steroid therapy
* Uncontrolled ascites, variceal hemorrhage or spontaneous bacterial peritonitis
* Pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00805805
Study Brief:
Protocol Section:
NCT00805805