Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients

Summary

This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.

Conditions

• Hepatitis B, Chronic

Interventions

DRUG

Entecavir

entecavir 0.5 mg QD

DRUG

Lamivudine

lamivudine 100 mg QD

Sponsors & Collaborators

• Severance Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Konkuk University Hospital

  collaborator OTHER

• Chung-Ang University

  collaborator OTHER

• Ajou University

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Keimyung University

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Korea University

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Inje University

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Yonsei University

  lead OTHER

Principal Investigators

• Kwnag-Hyub Han, MD · Yonsei Univsersity College of Medicine

• Jun Yong Park, MD · Yonsei Univsersity College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2014-07-31

Completion

2015-07-31

Countries

• South Korea

Study Locations