SNPMiner Trials by Shray Alag

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Report for Mutation M552V

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 Monitor™ 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 ---

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

HP:0200123: Chronic hepatitis
Genes 11
ALMS1 AIRE RFX5 RFXAP CD40LG RFXANK KRT8 IL21R KRT18 C4B CIITA
Protein Mutations 9
A181V C282Y H63D L528M M552I M552V N236T Q80K Y93H
SNP 3
rs12979860 rs4588 rs7041
HP:0012115: Hepatitis
Genes 91
TNPO3 AIRE CD247 PIK3R1 ATP7A TRAF3IP2 APC COG6 PGM1 C4B PIEZO1 AXIN1 COG8 POU2AF1 CD79A IL17RC TNFSF15 CD40LG TCF4 ITCH SKIV2L CYP7A1 IL17F BLNK TPP2 RFXAP TCF3 VPS33B SLC25A15 C1S CLEC7A FAS HSD3B7 KRT18 GUSB FASLG ALMS1 CYP7B1 CIITA TBX19 XIAP TP53 BTK LRRC8A RASGRP1 CASP10 CD3E PIK3CA XIAP VIPAS39 FOXP3 TTC7A TTC7A STAT1 IL12RB1 RFXANK IRF5 SH2D1A IL21R MST1 RFXANK CD3D CASP8 AMACR MMEL1 IL12A CD79B IGHM GLIS3 SHPK CIITA FAS MET IL17RA RFXAP IGLL1 SPIB KRT8 ATP7B BTK IGF2R PDGFRL RFX5 RFX5 ATP7B BTK GPR35 SERPINA1 PRKCD CTNNB1 SLC25A15
Protein Mutations 29
A181V A92T C282Y E62D G1764A H54Y H58C H63D L28M L31M L528M M204I M204V M28L M552I M552V N236T N370S P1028S P58A Q215S Q30H Q54H Q62E Q80K R30H Y93C Y93F Y93H
SNP 20
rs10813831 rs1127354 rs11795404 rs12356193 rs12979860 rs12992677 rs17037122 rs179008 rs2066842 rs2067085 rs2464266 rs3853839 rs41308230 rs4588 rs5743844 rs6592052 rs7041 rs7270101 rs7549785 rs8099917