HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
NCT ID: NCT03519113
Last Updated: 2020-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
186 participants
INTERVENTIONAL
2018-03-29
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Test group 1
GC1102 80,000 IU
GC1102 80,000 IU
recombinant human hepatitis B immunoglobulin
Test group 2
GC1102 100,000 IU
GC1102 100,000 IU
recombinant human hepatitis B immunoglobulin
Control group
I.V HBIG
I.V HBIG
human anti-hepatitis B Immunoglobulin
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Seung-Gyu Lee, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul Asan Medical Center
Locations
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Seoul Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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GC1102_P2b/3
Identifier Type: -
Identifier Source: org_study_id
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