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

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

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 Overview

• Status: Unknown
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: GC1102; Other: GC1102 Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: GC1102; NAs antivirals+GC1102 180,000 IU
Placebo Comparator: 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	Other: GC1102 Placebo; NAs antivirals+GC1102 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer	HBsAg titer	from baseline at Week 48 after the first dose of investigational product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer	HBsAg titer	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	from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Change in HBsAg titer	HBsAg titer	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	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	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	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	Proportion of subjects with 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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Sang Hoon Ahn, MD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: CHB; NAs; GC1102; GC1102B; Chronic Hepatitis B virus; NUC
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: GC1102B_P2a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No