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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513850
• Other study ID #: Hepabulin IV_LT_lll_2011
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: May 29, 2015
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• Hepabulin IV
I.V.

Locations

Country	Name	City	State
Korea, Republic of	SKChemicals	Seongnam	Gyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV(HBsAg) recurrence		52 weeks	No
Secondary	Time to recurrence		52 weeks	No
Secondary	Survival		52 weeks	No
Secondary	viral Marker of HBV		52 weeks	No