Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03801798
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

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

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: GC1102 Other: GC1102 Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: GC1102
NAs antivirals+GC1102 180,000 IU

Placebo Comparator: 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
Other: GC1102 Placebo
NAs antivirals+GC1102 Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer [ Time Frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product ]
    HBsAg titer

  2. Proportion of subjects with ≥ 1log10 reduction in HBsAg titer [ Time Frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product ]
    HBsAg titer

  3. Change in HBsAg titer [ Time Frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product ]
    HBsAg titer

  4. ALT response rates [ Time Frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product ]
    Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT >1.0 X ULN at baseline

  5. HBeAg seroconversion rates [ Time Frame: from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product ]
    Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline

  6. Rate of HBsAg loss [ Time Frame: from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product ]
    Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product

  7. Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point [ Time Frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product ]
    Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801798


Contacts
Layout table for location contacts
Contact: Jayoung Shon +82-31-260-1935 jyshon@greencross.com

Locations
Layout table for location information
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: S.H Ahn, M.D.    +82    __@__.com   
Sponsors and Collaborators
Green Cross Corporation
Investigators
Layout table for investigator information
Principal Investigator: Sang Hoon Ahn, MD Severance Hospital

Layout table for additonal information
Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03801798     History of Changes
Other Study ID Numbers: GC1102B_P2a
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Green Cross Corporation:
GC1102
GC1102B
Chronic Hepatitis B virus
CHB
NAs
NUC

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents