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

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

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)