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 HBeAgSeroconversion 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
|