SNPMiner Trials by Shray Alag

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Report for Mutation L528M

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 A PhaseII, Open-Label, Multinational, Multi-Centre, Sequential Group, Dose-Escalation Study to Assess the Safety and Antiviral Activity of LB80380 for 12 Weeks in Patients With Lamivudine-Refractory Chronic Hepatitis B

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 infection.

NCT00895596 Chronic Hepatitis B Drug: LB80380
MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic
HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

- 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 Monitorâ„¢ assay) - Screening ALT value between 1.5 and 10 x ULN Exclusion Criteria: - 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. --- M552V --- --- M552I --- --- L528M ---

Primary Outcomes

Measure: Mean serum HBV DNA level (log10) reduction from the baseline at Week 12

Time: Week 12

Secondary Outcomes

Measure: Proportion of patients with HBeAg seroconversion at 12 weeks Proportion of patients with HBsAg seroconversion at 12 weeks Proportion of patients with ALT normalization at 12 weeks Safety assessment during the whole study period

Time: Week 12

HPO Nodes