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A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

Information source: Green Cross Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Infection

Intervention: GC1102 50,000 IU (Biological); GC1102 80,000 IU (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Green Cross Corporation

Official(s) and/or principal investigator(s):
Sung-Gyu Lee, M.D., Principal Investigator, Affiliation: Seoul Asan Medical Center
Chang-Hee Lee, M.D., Study Director, Affiliation: Green Cross Corporation

Overall contact:
Eun-Gi Cho, Phone: 82-(0)31-260-9039, Email: ceg@greencross.com

Summary

This is a proof-of-concept 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.

Clinical Details

Official title: A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Recurrence rate of Hepatitis B

Secondary outcome:

Seroconversion rate of HBsAg or HBeAg

Seroconversion time of HBsAg or HBeAg

Overall survival rate

Geometric mean titer (GMT) of HBV DNA

Histological findings of hepatic graft

Incidence rate of Anti-GC1102 Antibody

Mutation rate of HBV DNA

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. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Given written informed consent

- Aged 19 - 65 years

- Expected liver transplantation related to hepatitis B

- Positive HBsAg

Exclusion Criteria:

- Patients has participated in any other clinical trial within 30 days

- Patients who are scheduled re-operation for liver transplantation

- Patients with are co-infected with HAV, HCV or HIV

- History of malignant tumor within 5 years except primary liver cancer

- Patients with moderate or severe renal disorder (serum creatinine > 1. 5 X ULM) or

anuria, acute renal failure or dialysis

- Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or

coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months

- History of anaphylaxis against active ingredient or excipients of study drug

- Patients who had been vaccinated with parenteral live vaccine (measles vaccine,

epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months

- Patients who had been treated with any other immuno globulin within 3 months

- Pregnant or breast-feeding women

- Women of childbearing potential who do not agree to use appropriate contraceptive

methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study

- Alcohol or drug abuse within 6 months

- Patients who has any clinically meaningful disease in investigator's judgement to

prevent participating in this study

Locations and Contacts

Eun-Gi Cho, Phone: 82-(0)31-260-9039, Email: ceg@greencross.com

Seoul Asan Medical Center, Seoul, Korea, Republic of; Recruiting
Sung-Gyu Lee, M.D., Phone: 82-(0)3010-5796
Additional Information

Starting date: February 2015
Last updated: February 11, 2015

Page last updated: August 20, 2015

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