Hepatitis B
Conditions
Keywords
GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC
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
Interventions
DRUGGC1102
NAs antivirals+GC1102 180,000 IU
OTHERGC1102 Placebo
NAs antivirals+GC1102 Placebo
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with ≥ 1log10 reduction in HBsAg titer | from baseline at Week 48 after the first dose of investigational product | HBsAg titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | HBsAg titer |
| Change in HBsAg titer | from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product | HBsAg titer |
| ALT response rates | from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product | 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 |
| 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 | HBsAg titer |
| Rate of HBsAg loss | from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product | 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 |
| 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 | Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point |
| HBeAg seroconversion rates | from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product | 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 |
Countries
South Korea
Outcome results
None listed