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

NCT05666453 | Terminated Phase 2

• 1 other identifier: SK_LIV_ABO
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 5

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Rate of biliary complications

  The number and rate of subjects with biliary complications including cholangitis, biliary leaks or biliary strictures for 48 weeks after liver transplantation (Experimental group vs. Comparator group)

  48 weeks

Secondary Outcomes (7)

• Rate of transplant rejection

  48 weeks

• Rate of Donor Specific Antibody (DSA)

  48 weeks

• Rate of antibody reaction by ABO subtype

  48 weeks

• Rate of Cytomegalovirus (CMV) infection

  48 weeks

• Rate of infectious complications

  48 weeks

Study Arms (3)

Treatment group

EXPERIMENTAL

LIV-GAMMA SN Inj. administration after ABO-incompatible liver transplantation

Biological: LIV-GAMMA SN Inj.

Comparator group

OTHER

No administration after ABO-incompatible liver transplantation

Other: No intervention

Reference group

OTHER

No administration after ABO-compatible liver transplantation

Other: No intervention

Interventions

LIV-GAMMA SN Inj. BIOLOGICAL

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.

Treatment group

No intervention OTHER

None of investigational drugs are administered to patients.

Comparator group; Reference group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Plasma Co., Ltd.: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Study Officials

• Nam-Joon Yi, MD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: April 25, 2022
• Primary Completion: May 7, 2024
• Study Completion: July 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

KR (5)