A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
NCT ID: NCT03801798
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2019-02-11
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
GC1102
NAs antivirals+GC1102 180,000 IU
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
GC1102 Placebo
NAs antivirals+GC1102 Placebo
Interventions
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GC1102
NAs antivirals+GC1102 180,000 IU
GC1102 Placebo
NAs antivirals+GC1102 Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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)
19 Years
65 Years
ALL
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Sang Hoon Ahn, MD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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GC1102B_P2a
Identifier Type: -
Identifier Source: org_study_id
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