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
Overview
- Phase
- Phase 2
- Intervention
- GC1102
- Conditions
- Hepatitis B
- Sponsor
- Green Cross Corporation
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
- Last Updated
- 6 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
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)
Arms & Interventions
NAs antivirals + GC1102 180,000 IU
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
Intervention: GC1102
NAs antivirals + GC1102 Placebo
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
Intervention: GC1102 Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Proportion of subjects with ≥ 1log10 reduction in HBsAg titer(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- Change in HBsAg titer(from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product)
- Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- ALT response rates(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- HBeAg seroconversion rates(from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product)
- Rate of HBsAg loss(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(from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product)