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

Phase 2

• Conditions: Hepatitis B
• Interventions: Drug: GC1102; Other: GC1102 Placebo

• Registration Number: NCT03801798
• Lead Sponsor: Green Cross Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-02-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAs antivirals + GC1102 180,000 IU	GC1102	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
NAs antivirals + GC1102 Placebo	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

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer	from baseline at Week 48 after the first dose of investigational product	HBsAg titer

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of