SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT00625560
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral
efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining
lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine
monotherapy.
Name: Entecavir
Description: entecavir 1.0 mg QDType: Drug
A
Name: Lamivudine
Description: lamivudine 100 mg QDType: Drug
B
Primary Outcomes
Measure: Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
Time: at Week 96
Secondary Outcomes
Measure: Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Time: at Week 48
Measure: Percentage number of patients who developed drug resistant mutations while on randomized therapy
Time: at Week 48 and Week 96
Measure: Change from baseline in mean HBV DNA
Time: at Week 48 and 96
Measure: Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Time: at Week 48 and 96
Measure: Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Time: Follow up period
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 M204V
Exclusion Criteria:
- All subjects will be tested for presence of M204V/I mutations in the YMDD motif at
baseline. --- M204V ---
Subjects with M204V/I mutations in the YMDD motif at baseline are not
eligible for the study. --- M204V ---
HPO Nodes
HPO: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 hr>