NCT01513850

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Hepabulin IV	I.V.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-01-20
• Last updated: 2015-06-01

Locations

1 site across 1 country: South Korea