Status:
UNKNOWN
Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Severance Hospital
Kangbuk Samsung Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 no...
Detailed Description
Currently, treatment guidelines for the management of chronic hepatitis B (CHB) recommend that patients with serum HBV DNA \> 105 copies/ml and elevated ALT levels greater than two times the upper lim...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT00823550
Start Date
January 1 2009
End Date
July 1 2015
Last Update
December 16 2010
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea