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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06589518
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 19 years or older.
2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:
ALT \< 3 x ULN and AST \< 3 x ULN
3. Patients taking antiviral therapy other than TAF for HBV prophylaxis.
4. Patients with a tacrolimus trough level maintained between 3-10 ng/mL.
5. Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.
Exclusion Criteria:
1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.
2. Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
3. Patients with concurrent viral infections (HCV, HIV).
4. Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.).
5. Patients with eGFR \<30 or those undergoing dialysis.
6. Pregnant or breastfeeding women.
7. Patients or their spouses/partners who do not agree to use medically acceptable and appropriate contraception methods\* during the clinical trial period.
* Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.
8 . Patients with a history of hypersensitivity to Tenofovir. 9 . Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
10\. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06589518
Study Brief:
Protocol Section:
NCT06589518