12 October 2018 : Original article
Safety and Efficacy of Once-Daily Prolonged-Release Tacrolimus in Living Donor Liver Transplantation: An Open-Label, Prospective, Single-Arm, Phase 4 Study
Eung Chang Lee BCDEF 1, Seong Hoon Kim ABCDEFG 1*, Sang-Jae Park CD 1DOI: 10.12659/AOT.910618
Ann Transplant 2018; 23:713-720
Supplementary Table 1 Inclusion and exclusion criteria.
| Inclusion criteria |
|---|
| – Adults aged 20 years or older at the time of providing an informed consent |
| – Patients who underwent LDLT at least 10–14 weeks prior to the Tac conversion from Bid-Tac to OD-Tac |
| – Patients who had a minimal Tac concentration (Cmin) or trough level of between 3–10 ng/ml from the day of the most recent LDLT until the day of Tac conversion |
| – For premenopausal women, those with a negative serum or urine pregnancy test at the screening and consent to practice effective birth control during the course of the clinical trial (Oral contraceptive pills are prohibited) |
| – Clinically stable patients in the opinion of the tester |
| – Patients who provided written informed consents after receiving adequate explanation about the purpose and risks of the clinical trial |
| – Patients who had previously received an organ transplantation other than liver or an auxiliary liver transplantation, or those who have used a bioartificial liver support system |
| – Patients who developed acute rejection after LDLT prior to Tac conversion |
| – Patients diagnosed with a novel malignant tumor after LDLT (Excluding those with basal cell carcinoma or squamous cell carcinoma of the skin that was successfully treated) |
| – Patients known to have a hypersensitivity to tacrolimus ingredients |
| – In the opinion of the tester, patients in an unstable medical state that may affect the purpose of this clinical trial |
| – Patients with any form of substance abuse, mental disorder, or condition that hinder effective communication with the tester as determined by the tester |
| – Patients who are currently participating in another clinical trial or have received pharmaceuticals for another clinical trial within 28 days of the Tac conversion |
| – Patients who are currently undergoing or have undergone (within 28 days of Tac conversion) a therapy prohibited for the purpose of this study |
| – Pregnant or nursing women |
| – Patients known to be human immunodeficiency virus (HIV)-positive |
| – Patients with a high possibility of missing the scheduled visits per the research plan |
| – Patients determined by the tester to have a clinically significant renal dysfunction or patients whose serum creatinine level exceeded 1.6 mg/dL or estimated glomerular filtration rate (eGFR) was below 30 mL/min prior to Tac conversion |
| – Patients determined by the tester to have a clinically significant liver dysfunction or patients whose liver function test parameters increased more than three-fold of the normal range prior to Tac conversion |