Clinical trial NCT05666453: A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation
Official title: A Multi-center, Prospective, Randomized, Controlled, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Immunoglobulin to Prevent Biliary Complications After ABO Incompatible Adult to Adult Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Transplantation
Lead sponsor: SK Plasma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver transplantation (LDLT). The primary objective of this study is to determine the incidence rate of biliary complications for 48 weeks after liver transplantation. Incidence rate of transplant rejection, DSA, antibody reaction, CMV infection, infectious complications, DIHBS and recurrence rate of HCC as well as adverse events are assessed as additional efficacy and safety endpoints in this study.


Eligibility criteria: Inclusion Criteria:

* Completed informed consent process
* Male or female aged ≥19 years and \<75 years
* Patients scheduled hospitalization for liver transplantation

Exclusion Criteria:

* Patients who are scheduled or have history of re-transplantation or multiorgan transplantation
* Patients receiving living donor in emergency
* Patients with Donor Specific Antibody (DSA) ≥ MFI 10,000 or Human Leukocyte Antigen (HLA) crossmatch (+) cytotoxic T-cell ≥ 1:32
* Patients with a history of biliary tract disease
* Patients who plasma exchange is forbidden (with a history of allergic or anaphylactic reaction to FFP, albumin, heparin, etc.)
* Patients with a history of specific medical conditions

  * Severe renal failure (eGFR \< 30 mL/min/1.73 m\^2 at screening)
  * Deep Vein Thrombosis (DVT) or thrombotic complications from Intravenous Immunoglobulin (IVIg) therapy
  * Cerebrovascular or cardiovascular disease (Hyperviscosity syndrome, Transient Ischemic Attack (TIA), Stroke, Thromboembolism, Unstable angina, etc.)
  * Clinical state causing secondary immunodeficiency (Leukemia, Lymphoma, Multiple myeloma, HIV infection, Chronic or Cyclic neutropenia (Absolute neutrophil \< 500/mm\^3), etc.)
  * Uncontrolled hypertension (Systolic blood pressure \> 160 mmHg or Diastolic blood pressure \> 100 mmHg)
  * Hemolytic or hemorrhagic anemia
  * Decreased cardiac functions
  * Bacterial, fungal or viral infection making liver transplantation forbidden
* Intraductal or vascular infiltration observed in patients with hepatocellular carcinoma using medical imaging before liver transplantation
* Patients metastasized to organs except for liver or diagnosed cancer except for liver cancer and squamous cell carcinoma within 5 years from screening
* Patients with sepsis
* Patients who had interventional therapy in blood vessels (hepatic vein, portal vein, hepatic artery, etc.) or bile ducts before LDLT
* Patients who have allergy or hypersensitivity to blood products, blood-derived products, IVIg or immunoglobulin G (IgG) products
* Patients who have immunoglobulin A (IgA) deficiency or anti-IgA antibody
* Patients who are pregnant and nursing
* Patients unwilling to use adequate method of contraception (hormonal methods, intrauterine device or intrauterine system, vasectomy, tubal ligation, etc.) during this study
* Patients who had received other investigational products within 8 weeks from complete consent or who are scheduled to receive other investigational products during this study
* Others whom the investigator considers ineligible for the study.

Primary outcomes:
measure: Rate of biliary complications
timeFrame: 48 weeks
Secondary outcomes:
measure: Rate of transplant rejection
timeFrame: 48 weeks
measure: Rate of Donor Specific Antibody (DSA)
timeFrame: 48 weeks
measure: Rate of antibody reaction by ABO subtype
timeFrame: 48 weeks
measure: Rate of Cytomegalovirus (CMV) infection
timeFrame: 48 weeks
measure: Rate of infectious complications
timeFrame: 48 weeks
measure: Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS)
timeFrame: 48 weeks
measure: Recurrence rate of Hepatocellular Carcinoma (HCC)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Nam-Joon Yi, MD
role: STUDY_CHAIR
References: