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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02287857
Eligibility Criteria:
Inclusion Criteria:
* The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
* Aged 18 to 65 years old，male or female
* Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA\> 105copies/ml； HBeAg-negative subjects, HBV-DNA\> 104copies/ml.
* 2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
* Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
* Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
* WBC ≥ 3.5 × 109 / L, PLT ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.
* Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.
* Patients signed an informed consent form and compliance was good.
Exclusion Criteria:
* Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
* Patients with cirrhosis or liver cancer.
* Pregnant woman, lactating women .
* Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
* Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
* Patients allergic for study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02287857
Study Brief:
Protocol Section:
NCT02287857