Clinical trial NCT01766518: The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)
Official title: Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Evidence of Liver Transplantation
Keywords: liver transplantation
LT
Mycophenolate mofetil
MMF
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Rate of acute rejection
timeFrame: up to 26weeks
Secondary outcomes:
measure: Frequency, Time, Severity of acute rejection
timeFrame: up to 26 weeks
measure: Graft loss, Patient survival rate
timeFrame: up to 26weeks
measure: Kidney function test by e-GFR(Glomerular filtration rate)
timeFrame: up to 26weeks
measure: Questionnaire of gastrointestinal symptom assessment
timeFrame: screening visit, closing visit
measure: Questionnaire of gastrointestinal quality of life index
timeFrame: screening visit, closing visit
Other outcomes:
measure: Rate of adverse event
timeFrame: up to 26 weeks
measure: Laboratory test
timeFrame: up to 26weeks
measure: Physical exam, pulse rate et.
timeFrame: up to 26weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul ST Mary's Hospital
Study officials:
affiliation: Asan Medical Center
name: SungGyu Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: