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Completed

NCT Number: NCT01513850

A Confirmatory Study 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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SKChemicals

Seongnam, Gyunggi-do, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hepabulin IV

Drug

I.V.

Primary outcomes

  1. HBV(HBsAg) recurrence

    Time frame: 52 weeks

Secondary outcomes

  1. Time to recurrence

    Time frame: 52 weeks

  2. Survival

    Time frame: 52 weeks

  3. viral Marker of HBV

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2012
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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