A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: GC1102
* Other: GC1102 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAs antivirals + GC1102 180,000 IU<br>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 | Drug: GC1102<br>* NAs antivirals+GC1102 180,000 IU<br>|
| Placebo Comparator: NAs antivirals + GC1102 Placebo<br>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 | Other: GC1102 Placebo<br>* NAs antivirals+GC1102 Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC