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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02075294
Eligibility Criteria:
Inclusion Criteria:
1. Age≥18 years
2. HBsAg positive for more than 6 months before enrollment
3. Serum HBVDNA \>2×104IU/ml and serum ALT \>80U/L or TBIL \< 34 umol/L for chronic hepatitis B
4. Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
5. Serum HBVDNA \>40 IU/ml for cirrhosis regardless of ALT and TBIL
Exclusion Criteria:
1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
2. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
3. Renal function: creatinine \>1.5 ULN or eGFR\< 50ml/min/1.73m2 before therapy
4. Combined with hepatocarcinoma before therapy
5. suspend therapy voluntarily
6. use other nephrotoxic drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02075294
Study Brief:
Protocol Section:
NCT02075294