NCT01766518UnknownPhase 4
Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.
Chong Kun Dang Pharmaceutical3 sites in 1 country120 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Rate of acute rejection
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
MY-REPT capsule
Experimental
MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally
Intervention: Mycophenolate mofetil (Drug)
Outcomes
Primary Outcomes
Rate of acute rejection
Time Frame: up to 26weeks
Rate acute rejection by liver biopsy
Secondary Outcomes
- 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)
Investigators
Study Sites (3)
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