Evidence of Liver Transplantation
Conditions
Keywords
liver transplantation, LT, Mycophenolate mofetil, MMF
Brief summary
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
Detailed description
Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation
Interventions
DRUGMycophenolate mofetil
MY-REPT capsule 500\ 1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient with primary liver transplantation recipients * Male and Female aged ≥19 and ≤65 * Patient with ABO blood type correspond with Donor's blood type * Patient who agreement with written informed consent * Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception
Exclusion criteria
* Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current * Patient with multi-organ transplantation recipient * Patient with dual-graft transplantation recipient * Patient who used body artificial liver before LT * Cr level \>2.0mg/dL in screening * WBC \<2,000/mm3 or ANC \<900/mm3 or PLT \<30,000/mm3 in screening * Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible * Patient who experienced severe infection (need to treatment) * Patient or Donor with HIV positive * Patient who need to treat with immunosuppressant or chemistry therapy * Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute rejection | up to 26weeks | Rate acute rejection by liver biopsy |
Secondary
| Measure | Time frame |
|---|---|
| Graft loss, Patient survival rate | up to 26weeks |
| Kidney function test by e-GFR(Glomerular filtration rate) | up to 26weeks |
| Questionnaire of gastrointestinal symptom assessment | screening visit, closing visit |
| Questionnaire of gastrointestinal quality of life index | screening visit, closing visit |
| Frequency, Time, Severity of acute rejection | up to 26 weeks |
Other
| Measure | Time frame |
|---|---|
| Physical exam, pulse rate et. | up to 26weeks |
| Laboratory test | up to 26weeks |
| Rate of adverse event | up to 26 weeks |
Countries
South Korea
Contacts
Primary ContactSungGyu Lee, Ph.D
Outcome results
None listed