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Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MY-REPT capsule | Experimental | MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil | Drug | MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute rejection | Rate acute rejection by liver biopsy | up to 26weeks |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse event | up to 26 weeks | |
| Laboratory test | up to 26weeks | |
| Physical exam, pulse rate et. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SungGyu Lee, Ph.D | Contact | +82 2 3010 7182 | sglee2@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| SungGyu Lee, Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| up to 26weeks |
| Questionnaire of gastrointestinal symptom assessment | screening visit, closing visit |
| Questionnaire of gastrointestinal quality of life index | screening visit, closing visit |
| up to 26weeks |
| Samsung Medical Center | Completed | Seoul | South Korea |
| Seoul ST Mary's Hospital | Completed | Seoul | South Korea |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |