Status:
UNKNOWN
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
Lead Sponsor:
LG Life Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-66 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B ...
Detailed Description
LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences...
Eligibility Criteria
Inclusion
- The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study
Exclusion
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- Decompensated liver disease
- ALT \> 10 x ULN
- Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min
- Alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
- Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
- Pregnancy or breast-feeding
- Patient is currently abusing alcohol or illicit drugs
- Significant systemic illnesses other than liver diseases
- Presence of other causes of liver disease
- Plan for liver transplantation
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01242787
Start Date
August 1 2010
End Date
September 1 2012
Last Update
April 16 2012
Active Locations (2)
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1
Queen Mary Hospital
Hong Kong, China
2
Severance Hospital of Yonsei University and other 8 sites in Korea
Seoul, South Korea