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

Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.

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

Study Overview

• Status: Unknown
• Conditions: Evidence of Liver Transplantation
• Intervention / Treatment: Drug: Mycophenolate mofetil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: SungGyu Lee, Ph.D; Phone Number: +82 2 3010 7182; Email: sglee2@amc.ac.kr
    • Principal Investigator: SungGyu Lee, Ph.D
  • Seoul, Korea, Republic of
    • Completed
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Completed
    • Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: MY-REPT capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute rejection	Rate acute rejection by liver biopsy	up to 26weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Rate of adverse event	up to 26 weeks
Laboratory test	up to 26weeks
Physical exam, pulse rate et.	up to 26weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: SungGyu Lee, Ph.D, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: liver transplantation; MMF; Mycophenolate mofetil; LT
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: m307LTP09D