Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304315
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2014-11-26
Brief Title:
A Phase 2 Study of GC1102 Recombinant Hepatitis B Immunoglobulin in HBV-related Liver Transplant Recipients
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50000IU of GC1102 or with high dose 80000IU and be followed up till 28 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None