SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00625560

Developed by Shray Alag, 2019.
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 Hepatitis A Hepatitis B Hepatitis B, Chronic
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 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