Clinical trial NCT02304315: A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B Infection
Keywords: HBV-related liver transplantation
Hepatitis B Immuno Globulin
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2014-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Recurrence rate of Hepatitis B
timeFrame: 28 weeks
Secondary outcomes:
measure: Seroconversion rate of HBsAg or HBeAg
timeFrame: 28 weeks
measure: Seroconversion time of HBsAg or HBeAg
timeFrame: 28 weeks
measure: Overall survival rate
timeFrame: 28 weeks
measure: Geometric mean titer (GMT) of HBV DNA
timeFrame: Day 6, 28, 59, 84, 112, 140, 158, 196
measure: Histological findings of hepatic graft
timeFrame: Baseline
measure: Incidence rate of Anti-GC1102 Antibody
timeFrame: 28 weeks
measure: Mutation rate of HBV DNA
timeFrame: 28 weeks
Other outcomes:
measure: Adverse events
timeFrame: 28 weeks
measure: Clinical abnormalities in physical exam, vital signs, and/or laboratory
timeFrame: 28 weeks
measure: Infusion reactions
timeFrame: 72 hours
measure: Pharmacokinetic parameters of GC1102 titer (C trough, t 1/2b, AUC, C max, and T max)
timeFrame: Day 6, 28, 59, 84, 112, 140, 158, 196
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
Study officials:
affiliation: Seoul Asan Medical Center
name: Sung-Gyu Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GC Biopharma Corp
name: Chang-Hee Lee, M.D.
role: STUDY_DIRECTOR
References: