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

This study has been completed.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
First received: January 16, 2012
Last updated: May 29, 2015
Last verified: May 2015
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Condition Intervention Phase
Hepatitis B
Drug: Hepabulin IV
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • HBV(HBsAg) recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: October 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepabulin IV Drug: Hepabulin IV

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01513850

Korea, Republic of
Seongnam, Gyunggi-do, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Study Chair: Dong Goo Kim, MD, PhD St.Mary's Hospital, Catholic University Medical college
  More Information

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01513850     History of Changes
Other Study ID Numbers: Hepabulin IV_LT_lll_2011 
Study First Received: January 16, 2012
Last Updated: May 29, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
Liver Transplantation
HBV Recurrence
HBsAg Positive

ClinicalTrials.gov processed this record on May 26, 2016