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:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT02551250
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject older than 40 years of age at the enrollment
* Fulfill below conditions A and B
A. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
1. Histologically by liver biopsy;
2. Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
* Evidence of portal hypertension, including any of followings;
* The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
* The identification of esophageal or gastric varices on endoscopic examination
B. Risk Index larger than 2.33; Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100,000/mm3) + 0.74 (if the presence of HCV is positive).
Exclusion Criteria:
* Presence of liver cancer or other intrahepatic malignancy
* Has a history of malignancy within previous 5 years
* Is pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
99 Years
Study:
NCT02551250
Study Brief:
Protocol Section:
NCT02551250