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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT00823550
Eligibility Criteria:
Inclusion criteria
* Male and female, 18 years of age or older
* HBsAg positive for more than 6 months
* Serum HBV DNA \> 2,000 IU/ml
* Serum ALT \< 2 X ULN on two consecutive occasions at least 3 months apart
* Naïve to nucleoside or nucleotide therapy
* On liver biopsy, fibrosis score ≥ 3 according to METAVIR scoring system (within 2 years of Day 0)
* If liver biopsy is not available, subjects must have two of the following items
* Overt findings of cirrhosis by radiologic evidence (MRI, CT, US)
* Gastrointestinal varices
* Platelet count \< 100,000,Splenomegaly (Spleen size - 12cm)
* The patient who is willing and able to provide written informed consent to participate in this study
Exclusion criteria
* A history of SBP, variceal bleeding, HEP, HCC
* Decompensated liver disease (Child-Pugh score \> 10)
* Co-infected with HCV or HIV
* History of any other forms of liver disease.
* Patient who is pregnant or breastfeeding
* Treatment with immunosuppressive, immunomodulatory agents or antiviral agents within 6 months prior to study entry
* A history of liver transplantation or planned for liver transplantation
* A history of any other medical disease or condition that would make the patients unsuitable for the study.
* Patient is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years.
* Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00823550
Study Brief:
Protocol Section:
NCT00823550