NCT03801798

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

January 8, 2019

Last Update Submit

December 11, 2019

Conditions

Hepatitis B

Keywords

GC1102GC1102BChronic Hepatitis B virusCHBNAsNUC

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with ≥ 1log10 reduction in HBsAg titer

    HBsAg titer

    from baseline at Week 48 after the first dose of investigational product

Secondary Outcomes (7)

  • Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer

    from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product

  • Proportion of subjects with ≥ 1log10 reduction in HBsAg titer

    from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product

  • Change in HBsAg titer

    from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product

  • ALT response rates

    from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product

  • HBeAg seroconversion rates

    from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product

  • +2 more secondary outcomes

Study Arms (2)

NAs antivirals + GC1102 180,000 IU

EXPERIMENTAL

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

Drug: GC1102

NAs antivirals + GC1102 Placebo

PLACEBO COMPARATOR

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

Other: GC1102 Placebo

Interventions

GC1102DRUG

NAs antivirals+GC1102 180,000 IU

NAs antivirals + GC1102 180,000 IU
GC1102 PlaceboOTHER

NAs antivirals+GC1102 Placebo

NAs antivirals + GC1102 Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis BHepatitis B, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sang Hoon Ahn, MD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 14, 2019

Study Start

February 11, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

KR(1)