TO Compare the Triple Drug Therapy and Dual Therapy .

NCT02075242 | Unknown Phase 4 DMC

• 1 other identifier: 2011-0900
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

HBV

Outcome Measures

Primary Outcomes (1)

• rejection

  • Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy

  within 6months

Secondary Outcomes (2)

• rate of HBV

  within 6 months

• Graft survival rate

  within 6 months

Study Arms (2)

tacrolimus

ACTIVE COMPARATOR

Control group: Tacrolimus + Corticosteroid (dual oral therapy)

Drug: Tacrolimus

Mycophenolate Mofetil

EXPERIMENTAL

Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)

Drug: Mycophenolate Mofetil; Drug: Tacrolimus

Interventions

Mycophenolate Mofetil DRUG

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

Also known as: Tacrolimus + Mycophenolate Mofetil+Corticosteroid

Mycophenolate Mofetil

Tacrolimus DRUG

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

Also known as: Tacrolimus + Corticosteroid

Mycophenolate Mofetil; tacrolimus

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Korea, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis

Interventions

Mycophenolic Acid; Tacrolimus; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sung-Gyu Lee

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yun-kyoung kim

CONTACT

82-31-219-4467

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of surgery, Asan medical center

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

KR (1)