The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)
- Registration Number
- NCT01766518
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MY-REPT capsule Mycophenolate mofetil MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally
- Primary Outcome Measures
Name Time Method Rate of acute rejection up to 26weeks Rate acute rejection by liver biopsy
- Secondary Outcome Measures
Name Time Method Frequency, Time, Severity of acute rejection up to 26 weeks Kidney function test by e-GFR(Glomerular filtration rate) up to 26weeks Graft loss, Patient survival rate up to 26weeks Questionnaire of gastrointestinal symptom assessment screening visit, closing visit Questionnaire of gastrointestinal quality of life index screening visit, closing visit
Trial Locations
- Locations (3)
Seoul ST Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan medical center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of