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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766518
First Posted: January 11, 2013
Last Update Posted: November 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
  Purpose
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: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766518


Contacts
Contact: SungGyu Lee, Ph.D +82 2 3010 7182 sglee2@amc.seoul.kr

Locations
Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: SungGyu Lee, Ph.D    +82 2 3010 7182    sglee2@amc.ac.kr   
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
Investigators
Principal Investigator: SungGyu Lee, Ph.D Asan Medical Center
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01766518     History of Changes
Other Study ID Numbers: m307LTP09D
First Submitted: January 10, 2013
First Posted: January 11, 2013
Last Update Posted: November 7, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action