Status:
COMPLETED
Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B
Lead Sponsor:
LG Life Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis B infec...
Detailed Description
LB80380, an oral prodrug, is a promising candidate nucleoside analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the trea...
Eligibility Criteria
Inclusion
- Compensated chronic hepatitis B patient
- Presence of serum HBsAg for more than 6 months.
- Presence of HBeAg for more than 1 month with compensated liver disease
- Confirmation of YMDD mutants (M552V, M552I and its related double mutant at L528M) by genotyping of the YMDD motif using line probe assay (INNO-LiPA HBV DR assay)
- Screening HBV DNA value higher than or equal to 1,000,000 copies/mL (measured by the COBAS Amplicor HBV Monitor™ assay)
- Screening ALT value between 1.5 and 10 x ULN
Exclusion
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- Pregnancy or breast-feeding
- Previous treatment with nucleoside analogue or any other treatment for HBV except for lamivudine within 6 months prior to study entry
- Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
- De-compensated liver disease
- Screening alpha-fetoprotein (AFP) value \> 20 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC.
- Presence of anti-HBs at screening
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00895596
Start Date
March 1 2004
End Date
December 1 2007
Last Update
May 8 2009
Active Locations (4)
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1
Queen Mary Hospital
Hong Kong, China
2
Korea University Medical Center
Seoul, South Korea
3
Severance Hospital of Yonsei University
Seoul, South Korea
4
The Catholic University of Korea, Kangnam St. Mary's Hospital
Seoul, South Korea