TO Compare the Triple Drug Therapy and Dual Therapy .

NCT ID: NCT02075242

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief Summary

Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with Hepatitis B Virus(HBsAg) Positive

Conditions

HEPATITIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tacrolimus

Control group: Tacrolimus + Corticosteroid (dual oral therapy)

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product

Mycophenolate Mofetil

Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),

Tacrolimus

Intervention Type: DRUG

control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product

Interventions

Mycophenolate Mofetil

experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),

Intervention Type: DRUG

Tacrolimus

control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product

Intervention Type: DRUG

Other Intervention Names

Tacrolimus + Mycophenolate Mofetil+Corticosteroid; Tacrolimus + Corticosteroid

Eligibility Criteria

Inclusion Criteria

• Men or women at the age of 20 to 65

• Patients who will have primary Liver Transplantation becaused of Chronic Hepatitis B of HbsAg positive

• Having confirmed a result of HBsAg positive patients within 6 months prior to Screening point.

• Patients who will have Liver Transplantation from ABO-compatible or proper living donor ⑤ Patients who will receive investigational products for the entire period of clinical trial.

• Patients who have signed the informed consent after understanding of clinical trial's purpose and risk.

• For women of childbearing potential, pregnancy test negative from urine or blood AND women who agree to contraception for the entire period of clinical trial.

Exclusion Criteria

• Recipients who had Liver Transplantation OR who had or will have other organ transplantation

• Recipients who other organ transplantation in addition to liver at once.

• Recipients who will have Auxiliary Partial Orthotopic Liver Transplantation.

• Recipients who use a Bioartificial liver prior to Transplantation

• Cr > 2.0mg/dl at screening test

• Patients who had malignant tumor within the past 5 years OR have malignant tumor(except, successfully treated Skin's non-metastatic basal cell carcinoma, squamous cell carcinoma or primary hepatocellular carcinoma )

• Recipients had hepatocellular carcinoma whick is out of Milan criteria

• WBC<1,500/mm3 or ANC<900/mm3 or PLT<30,000/mm3 at Screening

• Investigator judge that a patient is not proper to enroll this study due to Severe digestive disorder at Screening

• Patients who have severe systemic infection (But the liver transplantation is excepted that performed after the infection is completely lost or well-controlled)

⑪ Recipients who had Liver transplantation from HBsAg positive donor

⑫ Recipients or Donors are HIV, HCV Positive

⑬ Patients who need to systemc chemotherapy or immunosuppressive therapy prior to transplantation or took immunosuppressants within 30 days prior to liver transplantation(except, investigational products per protocol and corticosteroid)

⑭ Patients who have hypersensitivity to mycophenolate, mycophenolate acid, ingredient of investigational products, tacrolimus , Macrolide antibiotic and Steroids

⑮ Patients who had been received or have been received other investigational products within 28 days prior to screening 16 Pregnant women and lactating women 17 Substance abuse patient, mentally defective person or patients who is not possible to participate in clinical trial by law 18 Investigator judge that a patient have communication disorder 19 Patients are not capable of visiting accor.ding to study visit schedule 20 Investigator judge that a patient is not proper to enroll this study, et cetera

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Gyu Lee

Professor, Department of surgery, Asan medical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Gyu Lee

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Korea, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

yun-kyoung kim

Role: CONTACT

82-31-219-4467

Facility Contacts

Sung-Gyu Lee

Role: primary

sglee2@amc.seoul.kr

Other Identifiers

2011-0900

Identifier Type: OTHER

Identifier Source: secondary_id

2011-0900

Identifier Type: -

Identifier Source: org_study_id