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

NCT ID: NCT03801798

Last Updated: 2019-12-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis B

Keywords

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GC1102 GC1102B Chronic Hepatitis B virus CHB NAs NUC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type EXPERIMENTAL

GC1102

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

GC1102 Placebo

Intervention Type OTHER

NAs antivirals+GC1102 Placebo

Interventions

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GC1102

NAs antivirals+GC1102 180,000 IU

Intervention Type DRUG

GC1102 Placebo

NAs antivirals+GC1102 Placebo

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

Other Identifiers

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GC1102B_P2a

Identifier Type: -

Identifier Source: org_study_id