HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

Hepatitis B Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519113
• Other study ID #: GC1102_P2b/3
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: March 29, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2019
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection

Intervention

Biological:
• GC1102 80,000 IU
recombinant human hepatitis B immunoglobulin
• GC1102 100,000 IU
recombinant human hepatitis B immunoglobulin
• I.V HBIG
human anti-hepatitis B Immunoglobulin

Locations

Country	Name	City	State
Korea, Republic of	Seoul Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic(PK) parameters	serum drug titer	1 year
Other	Area under curve(AUC)	area under the baseline corrected serum titer versus time curve from time 0 to time of the last measureable titer	1 year
Other	clearance(CL)	clearance	1 year
Other	Vdss	volume of distribution	1 year
Other	Vdss/CL	effective half-life	1 year
Other	Adverse events	Adverse events occured during clinical trials	1 year
Other	Clinical abnormalities	Clinical laboratory test	1 year
Primary	Prevention Failure rate of HBV	Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L	28weeks
Secondary	Recurrence rate of HBV	Seroconversion rate of HBsAg or HBeAg	28weeks
Secondary	Prophylactic failure rate of HBV	Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L	28weeks
Secondary	Recurrence duration	Seroconversion time of HBsAg or HBeAg	28weeks
Secondary	Overall survival rate	survival rate during 1 year	1 year
Secondary	Geometric mean titer of HBV DNA	Geometric mean titer(GMT) of HBV DNA	1 year
Secondary	Change of anti-HBe	anti-hepatitis B e(HBe)	1 year