HBV-associated Liver Transplant(LT) Patients by IV Inject... | NCT03519113

NCT03519113

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group 1	Experimental	GC1102 80,000 IU	Biological: GC1102 80,000 IU
Test group 2	Experimental	GC1102 100,000 IU	Biological: GC1102 100,000 IU
Control group	Active Comparator	I.V HBIG	Biological: I.V HBIG

Name	Type	Description	Arm Group Labels	Other Names
GC1102 80,000 IU	Biological	recombinant human hepatitis B immunoglobulin	Test group 1

Outcomes Module

Measure	Description	Time Frame
Prevention Failure rate of HBV	Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L	28weeks

Secondary Outcomes

Measure	Description	Time Frame
Recurrence rate of HBV	Seroconversion rate of HBsAg or HBeAg	28weeks
Prophylactic failure rate of HBV	Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

Other Outcomes

Measure	Description	Time Frame
Pharmacokinetic(PK) parameters	serum drug titer	1 year
Area under curve(AUC)	area under the baseline corrected serum titer versus time curve from time 0 to time of the last measureable titer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
Subject aged over 19 years at the time of consent provided
Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
Subject with HBsAg(+)

Exclusion Criteria:

Subject with planned reoperation following liver transplantation
Subject with hemophilia
Subject with a history of venous or arterial thrombosis
Subject with HAV, HCV or HIV infection
Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
Subject with hemolytic or blood loss anemia
Subject with IgA deficiency
Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
Subject with moderate to severe kidney disease (serum creatinine > 20mg/dL or anuria, kidney failure or dialysis)
Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening
Subject with severe heart failure(NYHA class III~IV), arrythmia requiring treatment
Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
Subject who had received estrogen or hormone alternative medicine
Pregnant or breast-feeding women
Woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(B-HCG) test within 28 days prior to dosing by urine pregnancy or Subject who refused to use a reliable method of contraception
Alcohol or drug abuse within 6 months
Subject who has participated in any other clinical trial within 30 days
Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections