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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Drug: Hepabulin IV

• Registration Number: NCT01513850
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

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

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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepabulin IV	Hepabulin IV	-

Primary Outcome Measures

Name	Time	Method
HBV(HBsAg) recurrence	52 weeks

Secondary Outcome Measures

Name	Time	Method
viral Marker of HBV	52 weeks
Time to recurrence	52 weeks
Survival	52 weeks

Trial Locations

Locations (1)

SKChemicals; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of