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Trial record 7 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

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

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ClinicalTrials.gov Identifier: NCT02075242
Recruitment Status : Unknown
Verified February 2014 by Sung-Gyu Lee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Sung-Gyu Lee, Asan Medical Center

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

Condition or disease Intervention/treatment Phase
HEPATITIS Drug: Mycophenolate Mofetil Drug: Tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016


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 Name: Tacrolimus + Corticosteroid

Experimental: Mycophenolate Mofetil
Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)
Drug: Mycophenolate Mofetil
experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),
Other Name: Tacrolimus + Mycophenolate Mofetil+Corticosteroid

Drug: Tacrolimus
control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product
Other Name: Tacrolimus + Corticosteroid




Primary Outcome Measures :
  1. rejection [ Time Frame: within 6months ]
    • Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy


Secondary Outcome Measures :
  1. rate of HBV [ Time Frame: within 6 months ]
    • Recurrence rate of HBV after liver transplantation for 24 weeks (HBsAg Positve)

  2. Graft survival rate [ Time Frame: within 6 months ]
    • Patients survival rate after liver transplantation for 24 weeks / Graft survival rate



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075242


Contacts
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Contact: yun-kyoung kim 82-31-219-4467

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Korea, Republic of
Contact: Sung-Gyu Lee       sglee2@amc.seoul.kr   
Principal Investigator: Sung-Gyu Lee         
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Gyu Lee Asan Medical Center

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Responsible Party: Sung-Gyu Lee, Professor, Department of surgery, Asan medical center, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02075242     History of Changes
Other Study ID Numbers: 2011-0900
2011-0900 ( Other Identifier: ASAN MEDICAL CENTER Institutional review board )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014
Keywords provided by Sung-Gyu Lee, Asan Medical Center:
HBV
Additional relevant MeSH terms:
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Mycophenolic Acid
Hepatitis
Liver Diseases
Digestive System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents