A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

This study is currently recruiting participants.

Verified December 2011 by SK Chemicals Co.,Ltd.

Sponsor:

Information provided by (Responsible Party):

SK Chemicals Co.,Ltd.

ClinicalTrials.gov Identifier:

NCT01513850

First received: January 16, 2012

Last updated: January 19, 2012

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 16, 2012
Last Updated Date	January 19, 2012
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2012)	HBV(HBsAg) recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01513850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2012)	Time to recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Survival [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] viral Marker of HBV [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Official Title ^ICMJE	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
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Hepatitis B Virus Recurrence
Intervention ^ICMJE	Drug: Hepabulin IV I.V.
Study Arm (s)	Experimental: Hepabulin IV Intervention: Drug: Hepabulin IV
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: HBsAg Positive candidate for HBV-related liver transplant Primary, single organ recipients written informed consent Exclusion Criteria: acute renal failure, Serum creatinin >1.5*ULN severe cardiac disease or other significant disease HAV, HCV or HIV positive Immunoglobulin A deficiency. History of hypersensitivity to Human Immunoglobulin. History of cancer within 5 years. (without HCC) History of alcohol or/and drug abuse. History organ transplantation. Within 30 days, participation in another clinical trial and use of an investigational product. Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01513850
Other Study ID Numbers ^ICMJE	Hepabulin IV_LT_lll_2011
Has Data Monitoring Committee	Not Provided
Responsible Party	SK Chemicals Co.,Ltd.
Study Sponsor ^ICMJE	SK Chemicals Co.,Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	SK Chemicals Co.,Ltd.
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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