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Clinical Trials/NCT03801798
NCT03801798UnknownPhase 2

A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B

Green Cross Corporation1 site in 1 country42 target enrollmentStarted: February 11, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
42
Locations
1
Primary Endpoint
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

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

Intervention: GC1102 (Drug)

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

Intervention: GC1102 Placebo (Other)

Outcomes

Primary Outcomes

Proportion of subjects with ≥ 1log10 reduction in HBsAg titer

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

HBsAg titer

Secondary Outcomes

  • 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)
  • 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)
  • 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)
  • Rate of HBsAg loss(from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product)
  • Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point(from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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