Clinical trial NCT03519113: HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
Official title: Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatitis B Infection
Keywords: HBV-related liver transplantation
Hepatitis B immunoglobulin
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 186
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

Detailed description: GC1102 is a new recombinant hepatitis B immunoglobulin (HBIG) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIG derived from blood plasma of human donors. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject with planned reoperation following liver transplantation
2. Subject with hemophilia
3. Subject with a history of venous or arterial thrombosis
4. Subject with HAV, HCV or HIV infection
5. Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
6. Subject with hemolytic or blood loss anemia
7. Subject with IgA deficiency
8. Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
9. Subject with moderate to severe kidney disease (serum creatinine \> 20mg/dL or anuria, kidney failure or dialysis)
10. 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
11. Subject with severe heart failure(NYHA class III\~IV), arrythmia requiring treatment
12. Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
13. Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
14. Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
15. Subject who had received estrogen or hormone alternative medicine
16. Pregnant or breast-feeding women
17. 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
18. Alcohol or drug abuse within 6 months
19. Subject who has participated in any other clinical trial within 30 days
20. Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

Primary outcomes:
measure: Prevention Failure rate of HBV
timeFrame: 28weeks
Secondary outcomes:
measure: Recurrence rate of HBV
timeFrame: 28weeks
measure: Prophylactic failure rate of HBV
timeFrame: 28weeks
measure: Recurrence duration
timeFrame: 28weeks
measure: Overall survival rate
timeFrame: 1 year
measure: Geometric mean titer of HBV DNA
timeFrame: 1 year
measure: Change of anti-HBe
timeFrame: 1 year
Other outcomes:
measure: Pharmacokinetic(PK) parameters
timeFrame: 1 year
measure: Area under curve(AUC)
timeFrame: 1 year
measure: clearance(CL)
timeFrame: 1 year
measure: Vdss
timeFrame: 1 year
measure: Vdss/CL
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Clinical abnormalities
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
Study officials:
affiliation: Seoul Asan Medical Center
name: Seung-Gyu Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: