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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01513850
First received: January 16, 2012
Last updated: December 8, 2013
Last verified: December 2013

January 16, 2012
December 8, 2013
October 2010
December 2013   (final data collection date for primary outcome measure)
HBV(HBsAg) recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01513850 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
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

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

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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
Drug: Hepabulin IV
I.V.
Experimental: Hepabulin IV
Intervention: Drug: Hepabulin IV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01513850
Hepabulin IV_LT_lll_2011
No
SK Chemicals Co.,Ltd.
SK Chemicals Co.,Ltd.
Not Provided
Not Provided
SK Chemicals Co.,Ltd.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP