Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03519113
Status:
UNKNOWN
Last Update Posted:
2020-01-30
First Post:
2018-03-20
Brief Title:
HBV-associated Liver TransplantLT Patients by IV Injecting GC1102
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Dose SelectionStep 1 Non-inferiorityStep 2 Phase IIIII Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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
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 80000100000 IU of GC1102 or IV HBIG and be followed up till 28 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None