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

Green Cross Corporation

Status and phase: Unknown; Phase 2

Conditions: Hepatitis B

Treatments: Drug: GC1102; Other: GC1102 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03801798

GC1102B_P2a

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

NAs antivirals + GC1102 180,000 IU

Experimental group

Description:

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

Treatment:

Drug: GC1102

NAs antivirals + GC1102 Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: GC1102 Placebo