A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

A Multi-center, Prospective, Randomized, Controlled, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IVIg to Prevent Biliary Complications After ABO-Incompatible Living Donor Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666453
• Other study ID #: IVIg_ABO_II_2021
• Status: Recruiting
• Phase: Phase 2
• Start date: April 25, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2022
• Source: SK Plasma Co., Ltd.
• Contact: Byung Nam Chung
• Phone: 82-2-2008-2567
• Email: byung-nam.chung[@]sk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Biological:
• LIV-GAMMA SN Inj.
LIV-GAMMA SN Inj. is administered at a dose of 0.6 g/kg/day from anhepatic phase to Day 2 post-operative to patients undergoing ABO-incompatible liver transplantation as an experimental group.

Other:
• No intervention
None of investigational drugs are administered to patients.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Plasma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of biliary complications	Number of participants with and rate of biliary complications including cholangitis, biliary leaks or biliary strictures for 48 weeks after liver transplantation (Experiment group vs. Comparator group)	48 weeks
Secondary	Rate of transplant rejection	Number of participants with and rate of transplant rejection for 48 weeks after liver transplantation	48 weeks
Secondary	Rate of Donor Specific Antibody (DSA)	Number of participants with and rate of Donor Specific Antibody (DSA) for 48 weeks after liver transplantation	48 weeks
Secondary	Rate of antibody reaction by ABO subtype	Number of participants with and rate of antibody reaction by ABO subtype for 48 weeks after liver transplantation	48 weeks
Secondary	Rate of Cytomegalovirus (CMV) infection	Number of participants with and rate of Cytomegalovirus (CMV) infection for 48 weeks after liver transplantation	48 weeks
Secondary	Rate of infectious complications	Number of participants with and rate of infectious complications for 48 weeks after liver transplantation	48 weeks
Secondary	Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS)	Number of participants with and rate of Diffuse Intrahepatic Biliary Stricture (DIHBS) for 48 weeks after liver transplantation	48 weeks
Secondary	Recurrence rate of Hepatocellular Carcinoma (HCC)	Number of participants with and recurrence rate of Hepatocellular Carcinoma (HCC) for 48 weeks after liver transplantation	48 weeks
Secondary	Adverse event	Number of participants with and rate of adverse event during this study	48 weeks