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Liver TransplantationPhase 2NCT05666453

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

A Phase 2 study testing LIV-GAMMA SN Inj. in people with Liver Transplantation, run by SK Plasma Co., Ltd. at 5 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Liver Transplantation
What is being tested?
LIV-GAMMA SN Inj.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
5 sitesSouth Korea
Study dates
25 Apr 2022to 1 Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 24Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam

  • Chung-Ang University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
LIV-GAMMA SN Inj., No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • No interventionOther

    None of investigational drugs are administered to patients.

Study groups in NCT05666453
Study groupRoleWhat they receive
Treatment groupExperimentalLIV-GAMMA SN Inj. administration after ABO-incompatible liver transplantation
Receives: Biological: LIV-GAMMA SN Inj.
Comparator groupOtherNo administration after ABO-incompatible liver transplantation
Receives: Other: No intervention
Reference groupOtherNo administration after ABO-compatible liver transplantation
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 48 weeks

Secondary outcomes (7)

  1. Rate of transplant rejection

    The number and rate of subjects with transplant rejection for 48 weeks after liver transplantation

    Measured: 48 weeks

  2. Rate of Donor Specific Antibody (DSA)

    The number and rate of subjects with Donor Specific Antibody (DSA) for 48 weeks after liver transplantation

    Measured: 48 weeks

  3. Rate of antibody reaction by ABO subtype

    The number and rate of subjects with antibody reaction by ABO subtype analysis for 48 weeks after liver transplantation

    Measured: 48 weeks

  4. Rate of Cytomegalovirus (CMV) infection

    The number and rate of subjects with Cytomegalovirus (CMV) infection for 48 weeks after liver transplantation

    Measured: 48 weeks

  5. Rate of infectious complications

    The number and rate of subjects with infectious complications for 48 weeks after liver transplantation

    Measured: 48 weeks

  6. Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS)

    The number and rate of subjects with Diffuse Intrahepatic Biliary Stricture (DIHBS) for 48 weeks after liver transplantation

    Measured: 48 weeks

  7. Recurrence rate of Hepatocellular Carcinoma (HCC)

    The recurrence rate of subjects with Hepatocellular Carcinoma (HCC) for 48 weeks after liver transplantation

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start25 Apr 2022
  3. Primary completion7 May 2024
  4. Study completion1 Jul 2024

Why it stopped: Change of Clincal Development Plan

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666453
Sponsor's protocol ID
SK_LIV_ABO
Status last verified
Aug 2024
First submitted
17 Dec 2022
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIV-GAMMA SN Inj. in people with Liver Transplantation, run by SK Plasma Co., Ltd. at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change of Clincal Development Plan). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of biliary complications (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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