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

Green Cross Corporation42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis B

Interventions

GC1102DRUG

NAs antivirals+GC1102 180,000 IU

GC1102 PlaceboOTHER

NAs antivirals+GC1102 Placebo

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of subjects with ≥ 1log10 reduction in HBsAg titer

HBsAg titer

Time frame: from baseline at Week 48 after the first dose of investigational product

Secondary Outcomes

Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer

HBsAg titer

Time frame: 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

Time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product

Change in HBsAg titer

HBsAg titer

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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