TO Compare the Triple Drug Therapy and Dual Therapy . (OPTIMUS-A)

February 28, 2014 updated by: Sung-Gyu Lee, Asan Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: yun-kyoung kim
  • Phone Number: 82-31-219-4467

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tacrolimus
Control group: Tacrolimus + Corticosteroid (dual oral therapy)
Drug: Tacrolimus
control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product
Other Names:
  • Tacrolimus + Corticosteroid
Experimental: Mycophenolate Mofetil
Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)
Drug: Tacrolimus
control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product
Other Names:
  • Tacrolimus + Corticosteroid
Drug: Mycophenolate Mofetil
experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),
Other Names:
  • Tacrolimus + Mycophenolate Mofetil+Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rejection
Time Frame: within 6months
• Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy
within 6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of HBV
Time Frame: within 6 months
• Recurrence rate of HBV after liver transplantation for 24 weeks (HBsAg Positve)
within 6 months
Graft survival rate
Time Frame: within 6 months
• Patients survival rate after liver transplantation for 24 weeks / Graft survival rate
within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Sung-Gyu Lee, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0900 (Other Identifier: ASAN MEDICAL CENTER Institutional review board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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