Hepatitis BPhase 2NCT03801798
A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
A Phase 2 study testing GC1102 in people with Hepatitis B, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GC1102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Feb 2019to Dec 2021
- 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
- Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent
- Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form
- Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening
- Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test
Who cannot join
- Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B
- Patients who have history of liver transplantation, or liver transplantation schedule during the study
- Patients who co-infected with HAV, HCV, HDV and HIV
- Patient with Vasculitis
- Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening
- patient who have active infection(other than chronic hepatitis B infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B
- Conditions
- Hepatitis B
- Being tested
- GC1102, GC1102 Placebo
- Keywords
- GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC1102Drug
NAs antivirals+GC1102 180,000 IU
GC1102 PlaceboOther
NAs antivirals+GC1102 Placebo
| Study group | Role | What they receive |
|---|---|---|
| NAs antivirals + GC1102 180,000 IU | Experimental | All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
* V2 to V17 : IV bolus injection twice a week
* V18 to V33 : IV bolus injection once a week Receives: Drug: GC1102 |
| NAs antivirals + GC1102 Placebo | Placebo comparator | All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
* V2 to V17: IV bolus injection twice a week
* V18 to V33: IV bolus injection once a week Receives: Other: GC1102 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
HBsAg titer
Measured: from baseline at Week 48 after the first dose of investigational product
Secondary outcomes (7)
Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
HBsAg titer
Measured: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
HBsAg titer
Measured: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Change in HBsAg titer
HBsAg titer
Measured: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
ALT response rates
Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT >1.0 X ULN at baseline
Measured: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
HBeAg seroconversion rates
Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline
Measured: from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product
Rate of HBsAg loss
Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product
Measured: from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product
Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Measured: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start11 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Hoon Ahn, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801798
- Sponsor's protocol ID
- GC1102B_P2a
- Status last verified
- Dec 2019
- First submitted
- 8 Jan 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03801798
- Acronym / sponsor ID
- GC1102B_P2a
- Conditions
- Hepatitis B
- Keywords
- GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2019 (actual)
- 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.
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAs antivirals + GC1102 180,000 IU | Experimental | Drug: GC1102All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL * V2 to V17 : IV bolus injection twice a week * V18 to V33 : IV bolus injection once a week |
| NAs antivirals + GC1102 Placebo | Placebo comparator | Other: GC1102 PlaceboAll patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL * V2 to V17: IV bolus injection twice a week * V18 to V33: IV bolus injection once a week |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent
- Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form
- Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening
- Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test
Key exclusion criteria (6 listed)
- Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B
- Patients who have history of liver transplantation, or liver transplantation schedule during the study
- Patients who co-infected with HAV, HCV, HDV and HIV
- Patient with Vasculitis
- Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening
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 |
|---|---|---|
| GC1102NAs antivirals+GC1102 180,000 IU | Drug | NAs antivirals + GC1102 180,000 IU |
| GC1102 PlaceboNAs antivirals+GC1102 Placebo | Other | NAs antivirals + GC1102 Placebo |
Primary outcome
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
Time frame: from baseline at Week 48 after the first dose of investigational product
HBsAg titer
7 secondary outcomes
Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
Time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
Time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Change in HBsAg titer
Time frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
ALT response rates
Time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
HBeAg seroconversion rates
Time frame: from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product
Rate of HBsAg loss
Time frame: from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product
Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Time frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
Sang Hoon Ahn, MD principal investigator
Severance Hospital
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 in people with Hepatitis B, 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 6 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 13 Dec 2019. 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. Some participants in this study may receive a placebo. 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?
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?
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer (time frame: from baseline at Week 48 after the first dose of investigational product). 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 13 Dec 2019.