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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT05355467
Eligibility Criteria:
Ricovir® Group
Inclusion Criteria:
* Male or female aged more than 20 years old;
* CHB patients who have been treated with Viread® for more than 1 year;
* Serum HBV DNA level is undetectable (not detected or \<20 IU/mL) at screening;
* Informed consent must be obtained before the commencement of any screening procedures or study drugs
Exclusion Criteria:
* Patients with active HCC or other types of malignancy;
* Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
* Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
* Patients with alcohol dependence or addiction;
* Patients with autoimmune hepatitis;
* Patients with primary biliary cholangitis (PBC);
* Pregnancy, planning on getting pregnant, or breast-feeding;
* History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
* Not suitable for participating in this trial at the investigator's discretion.
Historical Control Group
Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:
* Male or female aged more than 20 years old;
* CHB patients who had been treated with Viread® for more than 1 year;
* Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or \<20 IU/mL) in serum at the time of discontinuation;
* Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
* The informed consent requirement will be waived based on the approval of IRB.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05355467
Study Brief:
Protocol Section:
NCT05355467