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

Launched by CHONG KUN DANG PHARMACEUTICAL · Jan 10, 2013

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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)