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Hepatitis B InfectionPhase 2/3NCT03519113

HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

A Phase 2/3 study testing GC1102 80,000 IU, GC1102 100,000 IU and I.V HBIG in people with Hepatitis B Infection, run by Green Cross Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hepatitis B Infection
What is being tested?
GC1102 80,000 IU, GC1102 100,000 IU and I.V HBIG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteSouth Korea
Study dates
29 Mar 2018to 30 Sep 2022
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
  • Subject aged over 19 years at the time of consent provided
  • Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
  • Subject with HBsAg(+)

Who cannot join

  • Subject with planned reoperation following liver transplantation
  • Subject with hemophilia
  • Subject with a history of venous or arterial thrombosis
  • Subject with HAV, HCV or HIV infection
  • Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
  • Subject with hemolytic or blood loss anemia
Show all 20Show fewer
  • Subject with IgA deficiency
  • Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
  • Subject with moderate to severe kidney disease (serum creatinine > 20mg/dL or anuria, kidney failure or dialysis)
  • Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening
  • Subject with severe heart failure(NYHA class III~IV), arrythmia requiring treatment
  • Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
  • Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
  • Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
  • Subject who had received estrogen or hormone alternative medicine
  • Pregnant or breast-feeding women
  • Woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(B-HCG) test within 28 days prior to dosing by urine pregnancy or Subject who refused to use a reliable method of contraception
  • Alcohol or drug abuse within 6 months
  • Subject who has participated in any other clinical trial within 30 days
  • Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102

This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

Read the detailed description

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIG) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIG derived from blood plasma of human donors. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks.

Being tested
GC1102 80,000 IU, GC1102 100,000 IU, I.V HBIG
Keywords
HBV-related liver transplantation, Hepatitis B immunoglobulin
Medical subject headings
Hepatitis B

What participants receive

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

  • GC1102 80,000 IUBiological

    recombinant human hepatitis B immunoglobulin

  • GC1102 100,000 IUBiological

    recombinant human hepatitis B immunoglobulin

  • I.V HBIGBiological

    human anti-hepatitis B Immunoglobulin

Study groups in NCT03519113
Study groupRoleWhat they receive
Test group 1ExperimentalGC1102 80,000 IU
Receives: Biological: GC1102 80,000 IU
Test group 2ExperimentalGC1102 100,000 IU
Receives: Biological: GC1102 100,000 IU
Control groupActive comparatorI.V HBIG
Receives: Biological: I.V HBIG

What is being measured

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

  1. Prevention Failure rate of HBV

    Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

    Measured: 28weeks

Secondary outcomes (6)

  1. Recurrence rate of HBV

    Seroconversion rate of HBsAg or HBeAg

    Measured: 28weeks

  2. Prophylactic failure rate of HBV

    Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

    Measured: 28weeks

  3. Recurrence duration

    Seroconversion time of HBsAg or HBeAg

    Measured: 28weeks

  4. Overall survival rate

    survival rate during 1 year

    Measured: 1 year

  5. Geometric mean titer of HBV DNA

    Geometric mean titer(GMT) of HBV DNA

    Measured: 1 year

  6. Change of anti-HBe

    anti-hepatitis B e(HBe)

    Measured: 1 year

Timeline

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

  1. First posted8 May 2018
  2. Study start29 Mar 2018
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03519113
Sponsor's protocol ID
GC1102_P2b/3
Status last verified
Oct 2019
First submitted
20 Mar 2018
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GC1102 80,000 IU, GC1102 100,000 IU and I.V HBIG in people with Hepatitis B Infection, run by Green Cross Corporation at 1 site 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

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?

Prevention Failure rate of HBV (time frame: 28weeks). 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 NCT03519113.

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 Jan 2020.

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