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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT00713934
Eligibility Criteria:
Inclusion Criteria:
* Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
* Alkaline phosphatase between 2 X to 3X normal value
* liver Cirrhosis in Sonography study
* Incomplete response to UDCA after 6 months of treatment.
* Negative pregnancy test (female patients in fertile age)
* written consent
Exclusion Criteria:
* Presence of active hepatic encephalopathy
* Refractory ascites
* Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT \> 3 times normal in patients with autoimmune hepatitis)
* Hepatocellular carcinoma or other malignancies
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* HIV, HBV or HCV infection
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins
* INR\>2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00713934
Study Brief:
Protocol Section:
NCT00713934