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

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborators: Ajou University; Bristol-Myers Squibb; Chung-Ang University; Hallym University Medical Center; Hanyang University; Inha University Hospital; Inje University; Kangbuk Samsung Hospital; Keimyung University; Konkuk University Hospital; Korea University; Korea University Anam Hospital; Kyungpook National University; Kyungpook National University Hospital; Pusan National University Hospital; Severance Hospital; Soonchunhyang University Hospital; The Catholic University of Korea
• Treatments: Entecavir; Lamivudine

Criteria

Inclusion criteria

• Male and female, 18 years of age or older

• HBsAg positive for more than 6 months

• Serum HBV DNA > 2,000 IU/ml

• Serum ALT < 2 X ULN on two consecutive occasions at least 3 months apart

• Naïve to nucleoside or nucleotide therapy

• On liver biopsy, fibrosis score ≥ 3 according to METAVIR scoring system (within 2 years of Day 0)

• If liver biopsy is not available, subjects must have two of the following items

• Overt findings of cirrhosis by radiologic evidence (MRI, CT, US)

• Gastrointestinal varices

• Platelet count < 100,000,Splenomegaly (Spleen size - 12cm)

• The patient who is willing and able to provide written informed consent to participate in this study

Exclusion criteria

• A history of SBP, variceal bleeding, HEP, HCC

• Decompensated liver disease (Child-Pugh score > 10)

• Co-infected with HCV or HIV

• History of any other forms of liver disease.

• Patient who is pregnant or breastfeeding

• Treatment with immunosuppressive, immunomodulatory agents or antiviral agents within 6 months prior to study entry

• A history of liver transplantation or planned for liver transplantation

• A history of any other medical disease or condition that would make the patients unsuitable for the study.

• Patient is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years.

• Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.