Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-08 @ 6:37 AM
Study NCT ID:
NCT01513850
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Sponsor:
SK Chemicals Co., Ltd.
Organization:
Study Overview
Official Title:
A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Status:
COMPLETED
Status Verified Date:
2015-05
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:
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
Detailed Description:
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
Study Oversight
Has Oversight DMC:
False
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?: