Prospective, Randomized, Open-label, Single center, Case Control Study To Evaluate Impact Of Eglandin® (Alprostadil) On Incidence Of Antibody-mediated Rejection According To Length Of Use In ABO-incompatible Living Donor Liver Transplant Patient
- Conditions
- Not Applicable
- Registration Number
- KCT0006115
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 160
1. Patients who received ABO blood type incompatible living liver transplantation
2. Those who are over 19 years of age or under 80 years of age when filling out a written consent form
3. Those who voluntarily agreed in writing to participate in clinical trials
1. Patients undergoing liver retransplantation
2. Patients who have received another organ transplant or plan to receive it within one year
3. Patients receiving transplants other than liver at the same time
4. Patients who used biometric space before transplantation
5. Patients with a history of malignant tumors within the last 5 years or currently (except for non-metastatic basal or plate cell carcinoma/hepatocellular carcinoma of successfully treated skin)
6. Patients with severe systemic infection who require treatment (transplantation performed after the infection is completely eliminated or controlled is possible)
7. Transplant recipient or donor positive for HIV
8. Take other investigational drugs 30 days before screening (date of consent) or within 5 times half-life, whichever is longer.
9. Patients who are pregnant, nursing, or women of childbearing age who do not use proper contraception
10. Substance abuse patients, mentally handicapped persons, or persons who are legally unable to participate in clinical trials
11. Patients with severe heart failure and bleeding patients who may have an increased risk due to the administration of the clinical trial drug
12. Patients with a history of hypersensitivity to THIS DRUG and its ingredients
13. When participation in clinical trials is inappropriate due to the judgment of other researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the frequency of antibody-mediated rejection (multiple hepatic biliary stenosis) within 1 year after administration of the investigational drug after administration of the investigational drug in patients with ABO blood type incompatible in vivo liver transplantation.;? The concentrations of total bilirubin/ALT/AST/ALP at 1 year after ABO blood type unsuitable living liver transplant were compared for each of the two groups. ?The safety is evaluated by observing bleeding or hepatic arterial thrombosis that occurred during the administration period of the clinical trial drug after ABO blood type incompatible living liver transplant. ? Evaluates safety through laboratory tests, measurement of vital signs, and observation of adverse reactions.
- Secondary Outcome Measures
Name Time Method 1. 1 year graft survival rate after ABO blood type incompatible living liver transplant 2. Patients 1 year after ABO blood type incompatible living liver transplant