Status:
UNKNOWN
A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
Lead Sponsor:
Green Cross Corporation
Conditions:
Hepatitis B
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03801798
Start Date
February 11 2019
End Date
December 1 2021
Last Update
December 13 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital
Seoul, South Korea