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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT02894918
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients \>18 and ≤65 years of age;
* Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment)
* Patients had achieved HBV DNA\<15 IU/ml、HBeAg\<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF )
Exclusion Criteria:
* Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication;
* Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN;
* A history of immunoregulation drug therapy within 1 year before entry including IFN and so on;
* Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on;
* Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months;
* A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter;
* A serum creatinine level that was more than 1.5 times the upper limit of the normal range;
* With other malignant tumors(exclude the cured ones);
* Severe organ dysfunction;
* With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on;
* Uncontrolled diabetes, hypertension or thyroid disease;
* Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period;
* Participate in other clinical studies at the same time;
* Patients unsuitable for the research;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02894918
Study Brief:
Protocol Section:
NCT02894918