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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical Identifier:
First received: January 10, 2013
Last updated: November 6, 2013
Last verified: November 2013
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients

Condition Intervention Phase
Evidence of Liver Transplantation
Drug: Mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.

Resource links provided by NLM:

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Rate of acute rejection [ Time Frame: up to 26weeks ]
    Rate acute rejection by liver biopsy

Secondary Outcome Measures:
  • Frequency, Time, Severity of acute rejection [ Time Frame: up to 26 weeks ]
  • Graft loss, Patient survival rate [ Time Frame: up to 26weeks ]
  • Kidney function test by e-GFR(Glomerular filtration rate) [ Time Frame: up to 26weeks ]
  • Questionnaire of gastrointestinal symptom assessment [ Time Frame: screening visit, closing visit ]
  • Questionnaire of gastrointestinal quality of life index [ Time Frame: screening visit, closing visit ]

Other Outcome Measures:
  • Rate of adverse event [ Time Frame: up to 26 weeks ]
  • Laboratory test [ Time Frame: up to 26weeks ]
  • Physical exam, pulse rate et. [ Time Frame: up to 26weeks ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MY-REPT capsule
MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally
Drug: Mycophenolate mofetil
MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
Other Name: MY-REPT capsule

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

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01766518

Contact: SungGyu Lee, Ph.D +82 2 3010 7182

Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: SungGyu Lee, Ph.D    +82 2 3010 7182   
Principal Investigator: SungGyu Lee, Ph.D         
Samsung Medical Center Completed
Seoul, Korea, Republic of
Seoul ST Mary's Hospital Completed
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Principal Investigator: SungGyu Lee, Ph.D Asan Medical Center
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01766518     History of Changes
Other Study ID Numbers: m307LTP09D
Study First Received: January 10, 2013
Last Updated: November 6, 2013

Keywords provided by Chong Kun Dang Pharmaceutical:
liver transplantation
Mycophenolate mofetil

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017