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

NCT01766518 | Unknown Phase 4

• 1 other identifier: m307LTP09D
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Evidence of Liver Transplantation

Keywords

liver transplantation; LT; Mycophenolate mofetil; MMF

Outcome Measures

Primary Outcomes (1)

• Rate of acute rejection

  Rate acute rejection by liver biopsy

  up to 26weeks

Secondary Outcomes (5)

• 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 Outcomes (3)

• Rate of adverse event

  up to 26 weeks

• Laboratory test

  up to 26weeks

• Physical exam, pulse rate et.

  up to 26weeks

Study Arms (1)

MY-REPT capsule

EXPERIMENTAL

MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally

Drug: Mycophenolate mofetil

Interventions

Mycophenolate mofetil DRUG

MY-REPT capsule 500\~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation

Also known as: MY-REPT capsule

MY-REPT capsule

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (3)

Asan medical center

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

COMPLETED

Seoul ST Mary's Hospital

Seoul, South Korea

COMPLETED

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• SungGyu Lee, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SungGyu Lee, Ph.D

CONTACT

+82 2 3010 7182; sglee2@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: November 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

KR (3)