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Trial record 59 of 339 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03519113
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 29, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Prevention Failure rate of HBV [ Time Frame: 28weeks ]
    Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L


Secondary Outcome Measures :
  1. Recurrence rate of HBV [ Time Frame: 28weeks ]
    Seroconversion rate of HBsAg or HBeAg

  2. Prophylactic failure rate of HBV [ Time Frame: 28weeks ]
    Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L

  3. Recurrence duration [ Time Frame: 28weeks ]
    Seroconversion time of HBsAg or HBeAg

  4. Overall survival rate [ Time Frame: 1 year ]
    survival rate during 1 year

  5. Geometric mean titer of HBV DNA [ Time Frame: 1 year ]
    Geometric mean titer(GMT) of HBV DNA

  6. Change of anti-HBe [ Time Frame: 1 year ]
    anti-hepatitis B e(HBe)


Other Outcome Measures:
  1. Pharmacokinetic(PK) parameters [ Time Frame: 1 year ]
    serum drug titer

  2. Area under curve(AUC) [ Time Frame: 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) [ Time Frame: 1 year ]
    clearance

  4. Vdss [ Time Frame: 1 year ]
    volume of distribution

  5. Vdss/CL [ Time Frame: 1 year ]
    effective half-life

  6. Adverse events [ Time Frame: 1 year ]
    Adverse events occured during clinical trials

  7. Clinical abnormalities [ Time Frame: 1 year ]
    Clinical laboratory test



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519113


Contacts
Contact: Sohye Yun 031-260-0866 ysh@greencross.com

Locations
Korea, Republic of
Seoul Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Gyu Lee, Ph.D         
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Seung-Gyu Lee, Ph.D Seoul Asan Medical Center

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03519113     History of Changes
Other Study ID Numbers: GC1102_P2b/3
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs