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:
NCT02095418
Eligibility Criteria:
Inclusion Criteria:
* 1.Male or female patients between 20-70 years 2.De novo patients 3.Recipients from living or cadaveric donors 4.Single organ recipient (liver only) 5.White Blood Cell(WBC) ≥ 3,000uL 6.Women of childbearing potential had to have a negative serum or urine pregnancy test within 1 week prior to beginning study treatment. Effective contraception has to be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy 7.Patients co-operative and able to complete all the assessment procedures. 8.Patients provided written informed consent
Exclusion Criteria:
1. Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
2. Incompatible A,B, and O blood group system.
3. Active infection
4. Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value \< 9 g/dL for adults receiving erythropoietin, 6.5 g/dL for adults not receiving erythropoietin, leukopenia (as defined by a white blood cell \[WBC\] value of \<1500/mm3) or thrombocytopenia (as defined by a platelet count of \<30,000/mm3).
5. Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant
6. Patient is allergic or intolerant to excipients, steroids, Mycophenolate mofetil(MMF), tacrolimus or basiliximab.
7. Patients with any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures.
8. The receipt of a new investigational drug within the previous 3 months
9. Pregnant or lactating females.
10. Women of child-bearing potential not willing to use a reliable form of contraception.
11. Previous organ transplantation
12. Patients who have diabetes mellitus prior to transplantation
13. Patients who have cancer other than liver cancer
14. Patients who have HGPRT(hypoxanthine quinine phosphoribosyl transferase) deficiency, Lesch-Nyhan syndrome, Kelly-Seegmiller syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02095418
Study Brief:
Protocol Section:
NCT02095418