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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC1102 | Drug | NAs antivirals+GC1102 180,000 IU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with ≥ 1log10 reduction in HBsAg titer | HBsAg titer | from baseline at Week 48 after the first dose of investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer | HBsAg titer | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Hoon Ahn, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| GC1102 Placebo |
| Other |
NAs antivirals+GC1102 Placebo |
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HBsAg titer
| from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product |
| Change in HBsAg titer | HBsAg titer | 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 | 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 | 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 | 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 | from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |