Hepatitis B InfectionPhase 2NCT02304315
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
A Phase 2 study testing GC1102 50,000 IU and GC1102 80,000 IU in people with Hepatitis B Infection, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
This is a proof-of-concept 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 to 65 years
- Conditions the study is for
- Hepatitis B Infection
- What is being tested?
- GC1102 50,000 IU and GC1102 80,000 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to May 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written informed consent
- Aged 19 - 65 years
- Expected liver transplantation related to hepatitis B
- Positive HBsAg
Who cannot join
- Patients has participated in any other clinical trial within 30 days
- Patients who are scheduled re-operation for liver transplantation
- Patients with are co-infected with HAV, HCV or HIV
- History of malignant tumor within 5 years except primary liver cancer
- Patients with moderate or severe renal disorder (serum creatinine > 1.5 X ULM) or anuria, acute renal failure or dialysis
- Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
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- History of anaphylaxis against active ingredient or excipients of study drug
- Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
- Patients who had been treated with any other immuno globulin within 3 months
- Pregnant or breast-feeding women
- Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
- Alcohol or drug abuse within 6 months
- Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients
This is a proof-of-concept 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. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.
- Conditions
- Hepatitis B Infection
- Being tested
- GC1102 50,000 IU, GC1102 80,000 IU
- Keywords
- HBV-related liver transplantation, Hepatitis B Immuno Globulin
- 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 50,000 IUBiological
a recombinant hepatitis B immunoglobulin
GC1102 80,000 IUBiological
a recombinant hepatitis B immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| GC1102 50,000 IU | Experimental | Anhepatic phase: 50,000 IU intravenous during surgery, Post-transplantation(1st week): 50,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 50,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 50,000 IU intravenous every 4 weeks. Receives: Biological: GC1102 50,000 IU |
| GC1102 80,000 IU | Experimental | Anhepatic phase: 80,000 IU intravenous during surgery, Post-transplantation(1st week): 80,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 80,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 80,000 IU intravenous every 4 weeks. Receives: Biological: GC1102 80,000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of Hepatitis B
Seroconversion rate of HBsAg or HBeAg
Measured: 28 weeks
Secondary outcomes (7)
Seroconversion rate of HBsAg or HBeAg
Measured: 28 weeks
Seroconversion time of HBsAg or HBeAg
Measured: 28 weeks
Overall survival rate
Measured: 28 weeks
Geometric mean titer (GMT) of HBV DNA
Measured: Day 6, 28, 59, 84, 112, 140, 158, 196
Histological findings of hepatic graft
if available
Measured: Baseline
Incidence rate of Anti-GC1102 Antibody
Measured: 28 weeks
Mutation rate of HBV DNA
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Gyu Lee, M.D., Principal investigator, Seoul Asan Medical CenterChang-Hee Lee, M.D., Study director, GC Biopharma Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304315
- Sponsor's protocol ID
- GC1102_P2
- Status last verified
- Dec 2015
- First submitted
- 26 Nov 2014
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT02304315
- Acronym / sponsor ID
- GC1102_P2
- Conditions
- Hepatitis B Infection
- Keywords
- HBV-related liver transplantation, Hepatitis B Immuno Globulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof-of-concept 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.
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. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC1102 50,000 IU | Experimental | Biological: GC1102 50,000 IUAnhepatic phase: 50,000 IU intravenous during surgery, Post-transplantation(1st week): 50,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 50,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 50,000 IU intravenous every 4 weeks. |
| GC1102 80,000 IU | Experimental | Biological: GC1102 80,000 IUAnhepatic phase: 80,000 IU intravenous during surgery, Post-transplantation(1st week): 80,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 80,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 80,000 IU intravenous every 4 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Given written informed consent
- Aged 19 - 65 years
- Expected liver transplantation related to hepatitis B
- Positive HBsAg
Key exclusion criteria (13 listed)
- Patients has participated in any other clinical trial within 30 days
- Patients who are scheduled re-operation for liver transplantation
- Patients with are co-infected with HAV, HCV or HIV
- History of malignant tumor within 5 years except primary liver cancer
- Patients with moderate or severe renal disorder (serum creatinine > 1.5 X ULM) or anuria, acute renal failure or dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC1102 50,000 IUa recombinant hepatitis B immunoglobulin | Biological | GC1102 50,000 IU |
| GC1102 80,000 IUa recombinant hepatitis B immunoglobulin | Biological | GC1102 80,000 IU |
Primary outcome
Recurrence rate of Hepatitis B
Time frame: 28 weeks
Seroconversion rate of HBsAg or HBeAg
7 secondary outcomes
Seroconversion rate of HBsAg or HBeAg
Time frame: 28 weeks
Seroconversion time of HBsAg or HBeAg
Time frame: 28 weeks
Overall survival rate
Time frame: 28 weeks
Geometric mean titer (GMT) of HBV DNA
Time frame: Day 6, 28, 59, 84, 112, 140, 158, 196
Histological findings of hepatic graft
Time frame: Baseline
Incidence rate of Anti-GC1102 Antibody
Time frame: 28 weeks
Mutation rate of HBV DNA
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Gyu Lee, M.D. principal investigator
Seoul Asan Medical Center
Chang-Hee Lee, M.D. study director
GC Biopharma Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC1102 50,000 IU and GC1102 80,000 IU 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 13 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: finished, as of the sponsor's last update on 30 Jun 2016. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence rate of Hepatitis B (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2016.