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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT05094869
Eligibility Criteria:
Inclusion Criteria:
* Registered on the CR-HepB platform
* Requiring or receiving antiviral therapy using nucleoside (acid) analogues (recommended as the first-line therapy in the 2019 Chinese Guidelines for Chronic Hepatitis B Prevention and Treatment )
* Diagnosed as compensatory hepatitis B cirrhosis, with the diagnostic criteria fitting any of the following criteria:
1. Diagnosis of Liver cirrhosis by histology;
2. Varicose veins in Esophageal and/or gastric fundus indicated by endoscopy;
3. Diagnosis of Liver cirrhosis by Imaging examination (abdominal ultrasound, CT, MRI) ;
4. Liver elasticity measurement \>12.0 kpa (ALT\<5×ULN)
5. Platelet PLT lower than the lower limit of normal value, and Serum albumin (ALB) lower than 35 g/L or international standardized ratio (INR) \>1.3.
* Completing the informed consent form
Exclusion Criteria:
* With any decompensated cirrhosis events, such as esophagogastric variceal rupture and bleeding, ascites, and hepatic encephalopathy;
* With any malignant tumor;
* With serious illness on any vital organs and systems, including heart, lungs, kidneys, and blood;
* Unsuitable for participating the study deemed by researchers;
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05094869
Study Brief:
Protocol Section:
NCT05094869