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Report for Clinical Trial NCT00625560

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA

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.

NCT00625560 Hepatitis B, Chronic
MeSH: Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis
HPO: Hepatitis

2 Interventions

Name: Entecavir

Description: entecavir 1.0 mg QD

Type: Drug

A

Name: Lamivudine

Description: lamivudine 100 mg QD

Type: 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 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3