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

Chong Kun Dang

Status and phase

Unknown

Phase 4

Conditions

Evidence of Liver Transplantation

Treatments

Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Industry

Identifiers

m307LTP09D

Details and patient eligibility

About

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

Full description

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

Enrollment

120 estimated patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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)