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

• Sponsor: Green Cross Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03519113
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 54.1
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Infection	Biological: GC1102 80,000 IU; Biological: GC1102 100,000 IU; Biological: I.V HBIG	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 29, 2018
• Anticipated Primary Completion Date: Mar 31, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group 1 GC1102 80,000 IU	Biological: GC1102 80,000 IU; recombinant human hepatitis B immunoglobulin
Experimental: Test group 2 GC1102 100,000 IU	Biological: GC1102 100,000 IU; recombinant human hepatitis B immunoglobulin
Active Comparator: Control group I.V HBIG	Biological: I.V HBIG; human anti-hepatitis B Immunoglobulin

Outcome Measures

Primary Outcome Measures

1. Prevention Failure rate of HBV [28weeks]

   Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

Secondary Outcome Measures

1. Recurrence rate of HBV [28weeks]

   Seroconversion rate of HBsAg or HBeAg

2. Prophylactic failure rate of HBV [28weeks]

   Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

3. Recurrence duration [28weeks]

   Seroconversion time of HBsAg or HBeAg

4. Overall survival rate [1 year]

   survival rate during 1 year

5. Geometric mean titer of HBV DNA [1 year]

   Geometric mean titer(GMT) of HBV DNA

6. Change of anti-HBe [1 year]

   anti-hepatitis B e(HBe)

Other Outcome Measures

1. Pharmacokinetic(PK) parameters [1 year]

   serum drug titer

2. Area under curve(AUC) [1 year]

   area under the baseline corrected serum titer versus time curve from time 0 to time of the last measureable titer

3. clearance(CL) [1 year]

   clearance

4. Vdss [1 year]

   volume of distribution

5. Vdss/CL [1 year]

   effective half-life

6. Adverse events [1 year]

   Adverse events occured during clinical trials

7. Clinical abnormalities [1 year]

   Clinical laboratory test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Green Cross Corporation

Investigators

• Principal Investigator: Seung-Gyu Lee, Ph.D, Seoul Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Green Cross Corporation
• ClinicalTrials.gov Identifier: NCT03519113
• Other Study ID Numbers: GC1102_P2b/3
• First Posted: May 8, 2018
• Last Update Posted: Jan 30, 2020
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Green Cross Corporation: HBV-related liver transplantation; Hepatitis B immunoglobulin
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis

Study Results

No Results Posted as of Jan 30, 2020