SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT00857675
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in
treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
Name: AAAA
Description: Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)Type: Drug
Adefovir Dipivoxil
Name: AAPA
Description: Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)Type: Drug
Adefovir Dipivoxil Adefovir Dipivoxil matched placebo
Name: PAAA
Description: Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)Type: Drug
Adefovir Dipivoxil Adefovir Dipivoxil matched placebo
Primary Outcomes
Measure: The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Time: Week 12
Secondary Outcomes
Measure: The proportion of subjects with ALT normalisation
Time: Week 52, 104, 156, 208, 260
Measure: log10 reduction in serum HBV DNA
Time: Week 52, 104, 156, 208, 260
Measure: The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Time: Week 52, 104, 156, 208, 260
Measure: The proportion of subjects with HBeAg loss
Time: Week 52, 104, 156, 208, 260
Measure: The proportion of subjects with HBeAg seroconversion
Time: Week 52, 104, 156, 208, 260
Measure: The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
Time: Week 52, 104, 156, 208, 260
Measure: The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
Time: Week 52, 104, 156, 208, 260
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 2 SNPs
SNPs
1 A181V
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T --- --- A181V ---
2 N236T
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T ---
HPO Nodes
HPO:Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE hr>Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG hr>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>