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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Treatments: Antiviral Agents

Criteria

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)