Clinical trial NCT03801798: A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis B
Keywords: GC1102
GC1102B
Chronic Hepatitis B virus
CHB
NAs
NUC
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
timeFrame: from baseline at Week 48 after the first dose of investigational product
Secondary outcomes:
measure: Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
timeFrame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
measure: Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
timeFrame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
measure: Change in HBsAg titer
timeFrame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
measure: ALT response rates
timeFrame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
measure: HBeAg seroconversion rates
timeFrame: from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product
measure: Rate of HBsAg loss
timeFrame: from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product
measure: Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
timeFrame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sang Hoon Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: