Liver transplant rejection MedDRA version: 17.1 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection System Organ Class: 100000004865
Conditions
Sponsors
Fujisawa Healthcare, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Legal guardian has been fully informed and has signed an IRB approved informed consent form/authorization. Patient, ages 7-12, has been fully informed and has signed an IRB approved assent form/authorization. 2. Patient is the recipient of a liver transplant at least six months prior to enrollment. 3. Patient is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has previously received an organ transplant other than a liver. 2. Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy or more than 2 rejection episodes within the last 12 months. 3. Patient is currently receiving sirolimus immunosuppression therapy. 4. Patient has any unstable medical condition that could interfere with the study objectives. 5. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment. 6. Patient has a history or presence of malignancy (except for treated basal or squamous cell carcinoma of the skin), serious active or recurrent infection or any medical condition or disorder that, in the opinion of the investigator, precludes the patient from participating in this study. 7. Patient has a known hypersensitivity to tacrolimus. 8. Patient is pregnant or lactating, for female patients who have started their menses. 9. Patient is unlikely to comply with the scheduled visits. 10. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator. 11. Patient is currently receiving any medications described in Appendix C. 12. Patient’s liver function is abnormal, as defined by AST/ALT > 2 x ULN at screening. 13. Patient’s renal function is abnormal, as defined by calculated creatinine clearance < 50 mL/min/m2 using the Schwartz formula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine and compare the pharmacokinetics of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release (MR) tacrolimus based immunosuppression regimen.;Secondary Objective: To determine the long-term safety and tolerability of tacrolimus in stable pediatric liver transplant patients converted from a Prograf based immunosuppression regimen to a modified release (MR) tacrolimus based immunosuppression regimen.;Primary end point(s): Cmin, AUC0-24, ;Timepoint(s) of evaluation of this end point: Days 1-7 for Prograf; Days 8-14 for Tacrolimus MR AUC0-24: Prograf day 7; tacrolimus MR day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cmax, Tmax; The assessment of safety and tolerability will be based upon clinical signs and symptoms, laboratory parameters, diagnostic tests and other relevant information.;Timepoint(s) of evaluation of this end point: Days 1-7 for Prograf; Days 8-14 for Tacrolimus MR Tmax: Prograf day 7; tacrolimus MR day 14 Safety and tolerability: Day 1, 7, 8, 10, 12, 14, 21, Month 1, 2, 3, 6, 9, 12, 15, 18 , 21, 24 | — |
Countries
United States
Contacts
Public ContactService Desk
Astellas Pharma Europe BV
Outcome results
None listed