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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00476060
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis (diagnosed by clinical, biochemical, sonographic, and histologic evidences of cirrhosis) (Patients will have histological documentation of cirrhosis before enrollment. However, for those with evidences of severe coagulopathy liver biopsy may not be performed)
* Evidences of decompensated liver disease at screening (e.g. child class B, or C)
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
* Active infectious disease
* Presences of severe underlying cardiac, pulmonary, or renal disease
* Alcohol use in the last 3 months before screening
* Use of hepatotoxic drugs in the last 3 months before screening
* Unwilling to assign the informed consent
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* Positive HIV ab
* Positive HBsAg with detectable HBV DNA PCR
* Positive HCV Ab with detectable HCV RNA PCR
* Active thrombosis of the portal or hepatic veins
* Serum Cr \> 1.8 mg/dL at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00476060
Study Brief:
Protocol Section:
NCT00476060