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
  Purpose

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 ]

Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepabulin IV Drug: Hepabulin IV
I.V.

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT01513850

Locations
Korea, Republic of
SKChemicals
Seongnam, Gyunggi-do, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
  More Information

No publications provided

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: December 8, 2013
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014