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CompletedNCT01513850Updated Jun 1, 2015

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

A Phase 3 interventional study of Hepabulin IV in Hepatitis B, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by SK Chemicals Co., Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
87
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hepatitis B

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Keywords

  • Liver Transplantation
  • HBV
  • HBV Recurrence
  • HBsAg Positive
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 87 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HBsAg Positive candidate for HBV-related liver transplant
  • Primary, single organ recipients
  • written informed consent

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Hepabulin IV

    Drug: Hepabulin IV

Interventions

  • DrugHepabulin IV

    I.V.

06

What researchers measure

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

07

Study locations

1 site
  • SKChemicals
    Seongnam, Gyunggi-do, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01513850
Lead sponsor
SK Chemicals Co., Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2012
Start date
Oct 2010
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jun 1, 2015

Study contacts

Dong Goo Kim, MD, PhD
study chair · St.Mary's Hospital, Catholic University Medical college

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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