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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03801798
• Other study ID #: GC1102B_P2a
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 11, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• GC1102
NAs antivirals+GC1102 180,000 IU

Other:
• GC1102 Placebo
NAs antivirals+GC1102 Placebo

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with = 1log10 reduction in HBsAg titer	HBsAg titer	from baseline at Week 48 after the first dose of investigational product
Secondary	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
Secondary	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
Secondary	Change in HBsAg titer	HBsAg titer	from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
Secondary	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
Secondary	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
Secondary	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
Secondary	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