The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)

Study Overview
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Brief Summary
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Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients

Detailed Description
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Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation

Official Title
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Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.

Conditions
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Evidence of Liver Transplantation

Intervention / Treatment
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* Drug: Mycophenolate mofetil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MY-REPT capsule<br>MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally | Drug: Mycophenolate mofetil<br>* MY-REPT capsule 500 1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation<br>* Other names: MY-REPT capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute rejection | Rate acute rejection by liver biopsy | up to 26weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, Time, Severity of acute rejection |  | up to 26 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplantation, LT, Mycophenolate mofetil, MMF