Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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. 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: 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 ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: 52 weeks ]
  • Survival [ Time Frame: 52 weeks ]
  • viral Marker of HBV [ Time Frame: 52 weeks ]

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   (Adult)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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. 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

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

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases processed this record on May 23, 2017