Overview

Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

Status:
Recruiting
Trial end date:
2022-11-17
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Treatments:
Everolimus
Mycophenolic Acid
Criteria
* Inclusion Criteria:

[Time of screening]

- Patients who have transplanted in primary living donor liver in 35 days or who plan to
be transplanted in primary living donor liver.

- Over 20 years old(male or female)

- Agreement with written informed consent

[Time of randomization] - Patients who have transplanted liver within 4 weeks(25 days to 35
days)

* Exclusion Criteria

[Time of screening]

- Patients who have transplanted non-liver organs or have plan to be transplanted
non-liver organs.

- Patients with bioartificial liver (cell system)

- Patients who diagnosed with malignant tumor within 5 years [however, who have
recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer,
hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can
be enrolled]

- Patients with severe systemic infection

- Women who are pregnant or breast feeding or not agree to the proper use of
contraception during the trial

- Participated in other trial within 4 weeks

- In investigator's judgement

[Time of randomization]

- Patients with acute rejection who have been clinically treated after liver
transplantation.

- Patients with complication related to the hepatic artery such as hepatic artery
thrombosis at the time of randomization.

- At screening

- WBC <1,500/mm^3 or PLT <30,000/mm^3 or over 3 times upper than normal range of
liver function tests(T-bilirubin, AST, ALT) levels

- Protein/Creatinine ratio(urine test) > 1 or eGFR by MDRD< 30mL/min/1.73m^2 or
Total cholesterol > 350mg/dL or triglycerides > 500mg/dL

- Patients taking HCV(hepatitis C virus) Therapeutic Drugs

- Patients who had plasmapheresis within 1 week.

- Patents who had a record of taking mTOR inhibitor before.

- In investigator's judgement