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

Evidence of Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01766518
• Other study ID #: m307LTP09D
• Status: Recruiting
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: November 6, 2013
• Start date: November 2009
• Est. completion date: May 2014

Study information

• Verified date: November 2013
• Source: Chong Kun Dang Pharmaceutical
• Contact: SungGyu Lee, Ph.D
• Phone: +82 2 3010 7182
• Email: sglee2[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Intervention

Drug:
• Mycophenolate mofetil
MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul ST Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of adverse event		up to 26 weeks	Yes
Other	Laboratory test		up to 26weeks	Yes
Other	Physical exam, pulse rate et.		up to 26weeks	Yes
Primary	Rate of acute rejection	Rate acute rejection by liver biopsy	up to 26weeks	No
Secondary	Frequency, Time, Severity of acute rejection		up to 26 weeks	No
Secondary	Graft loss, Patient survival rate		up to 26weeks	No
Secondary	Kidney function test by e-GFR(Glomerular filtration rate)		up to 26weeks	No
Secondary	Questionnaire of gastrointestinal symptom assessment		screening visit, closing visit	No
Secondary	Questionnaire of gastrointestinal quality of life index		screening visit, closing visit	No