TO Compare the Triple Drug Therapy and Dual Therapy .

HEPATITIS Clinical Trial

— OPTIMUS-A  

Official title:

Open Label, Multi-center, Randomized Study to Compare of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation With Hepatitis B Virus(HBsAg) Positive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02075242
• Other study ID #: 2011-0900
• Secondary ID: 2011-0900
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2014
• Last updated: February 28, 2014
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2014
• Source: Asan Medical Center
• Contact: yun-kyoung kim
• Phone: 82-31-219-4467
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 ? 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)

? Recipients who had Liver transplantation from HBsAg positive donor

? Recipients or Donors are HIV, HCV Positive

? 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)

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

? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HEPATITIS

Intervention

Drug:
• Mycophenolate Mofetil
experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),
• Tacrolimus
control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rejection	• Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy	within 6months	No
Secondary	rate of HBV	• Recurrence rate of HBV after liver transplantation for 24 weeks (HBsAg Positve)	within 6 months	No
Secondary	Graft survival rate	• Patients survival rate after liver transplantation for 24 weeks / Graft survival rate	within 6 months	No