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

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ClinicalTrials.gov Identifier: NCT01513850
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

Brief Summary:
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Hepabulin IV Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hepabulin IV Drug: Hepabulin IV
I.V.



Primary Outcome Measures :
  1. HBV(HBsAg) recurrence [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: 52 weeks ]
  2. Survival [ Time Frame: 52 weeks ]
  3. viral Marker of HBV [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513850


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

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01513850     History of Changes
Other Study ID Numbers: Hepabulin IV_LT_lll_2011
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases