SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00895596

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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
MeSH: Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic
HPO: Chronic active hepatitis Chronic hepatitis Hepatitis

1 Interventions

Name: LB80380

Description: Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg

Type: Drug

LB80380 30mg LB80380 60mg LB80380 90mg, LB80380 150mg LB80380 240mg


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

Purpose: Treatment

Allocation: Non-Randomized


There are 3 SNPs

SNPs


1 L528M

- 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 ---


2 M552I

- 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 ---


3 M552V

- 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 ---



HPO Nodes


HPO:
Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG
Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3